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Announcement Deliverables Temp
1. Argon
Medical Devices
1445 Flat Creek Rd, Athens, Texas 75751 USA
Tel: 903-675-9321 Fax: 903-677-9397
[insert date]
Dear Argon Medical Devices Customer,
On [insert date], Argon Medical Devices is announcing its next generation Patient Moni-
toring (PTMO) family called the ArgoTrans. Inspired by your feedback, the
ArgoTrans is an innovative family of disposable blood pressure transducers with
a rich feature set.
The ArgoTrans family of disposable transducers combines proven electronics
with integrated components to provide a PTMO solution that produces a crisp, clear
wave form. The cable conļ¬guration has changed from a semi-rigid, ļ¬at cable to a more
ļ¬exible, pliable, round cable. The round cable design enables the clinician to move
the cable, without many of the restrictions of a ļ¬at cable, to an angle that best suits the
procedure.
The straight, ļ¬ow-through design and next generation Universal Steriļ¬oā¢ ļ¬ush device
enables rapid priming and de-bubbling of the transducer. Also, the Universal Steri-
ļ¬oā¢ ļ¬ush device gives the clinician a choice of priming methodsāpull tab or squeeze
wingsāfrom the same transducer. This is a unique feature not provided by other major
disposable blood pressure transducer manufacturers.
Over the next 90 days, Argon Medical Devices will be migrating all customersā cus-
tom transducer kits over to the next generation ArgoTrans family of disposable
blood transducers. If you have custom transducer kits, there is nothing you need to do.
The part numbers will remain the same. If you purchase the standard CDX and CDX-
press kits today, you will be able to continue ordering these products during this period.
Please see the attached PTMO brochure for the part numbers of the next generation
ArgoTrans family from Argon Medical Devices.
If you have any questions about these or any other Argon Medical Devices products,
please contact your Argon Sales Representative or Argonās Customer Service.
Regards,
Chris Haughey
Product Marketing Manager
2. Argon
Medical Devices
1445 Flat Creek Rd, Athens, Texas 75751 USA
Tel: 903-675-9321 Fax: 903-677-9397
ArgoTrans Announcement
Frequently Asked Questions
1. What is Argon announcing?
Argon is announcing the following today:
ā¢ ArgoTrans family of disposable blood pressure transducers;
ā¢ Enhanced Safety productsāSharpsācompliant Percutaneous Introducer
needles and needleāless, swabable stopcock for closed sampling
systems;
ā¢ Line extensions of the Jawz and Percutaneous Introducer families;
ā¢ On-line ordering capability for Argon customers to purchase standard
products.
2. Why did Argon develop its next generation transducer family?
Patient Monitoring (PTMO) is very important to Argon Medical Devices. As
part of our central product strategy, PTMO products satisfy many groups
within a hospitalācardiac catheter labs, ER, ICU, CCU, OR and post-oper-
ation. After more than 10 years of experience satisfying the patient moni-
toring needs in critical care, Argon asked its customers to comment on the
current product family, as well as what they thought about Argonās competi-
tion. The ArgoTrans is the result of those discussions.
3. What are the beneļ¬ts to the customer?
There are three main beneļ¬t areas customers are expected to experience
with the ArgoTrans family. First, Argon has combined proven electron-
ics from the current CDX product line within a completely molded package.
This should shorten the time required to qualify the ArgoTrans.
Next, the straight ļ¬ow-through path of the ArgoTrans when coupled
with the innovative Universal Steriļ¬oā¢ ļ¬ush device (Model 2), ļ¬ushing the
line and zeroing the system is easier than ever. The ArgoTrans gives
the clinician the ļ¬exibility to ļ¬ush the system as he choosesāgently pull
the tab or squeeze the side wings. However, in Argonās Clinical Validation,
using the side wings proved to be more popular than the pull tabāmost
3. Argon
Medical Devices
transducer manufacturers feature a pull tab with their products.
Third, the ArgoTrans has two base models as building blocks on which
PTMO solutions can be built. Model 1 is a stand-alone transducer with a variety
of cable lengths from 14ā to 60ā. Model 2 includes the Universal Steriļ¬oā¢ ļ¬ush
device. From this model, very elaborate PTMO solutions can be created. Each
ArgoTrans Model 2 comes standard with either a Macro or Micro-drip IV
system.
For more involved procedures, bifurcated and trifurcated conļ¬gurations are avail-
able. If the hospital is focused on using safetyāengineered products, Argon of-
fers ArgoTrans KeepSafeā¢ Closed Sampling systems. These enable the
sampling of blood while minimizing the risk of needle-sticks or exposure to bodily
ļ¬uids.
4. How does the ArgoTrans compare to the current Argon CDX III and CDX
press transducers?
ArgoTrans Model 1 vs. CDX III
The ArgoTrans Model 1 is nearly identical to the CDX III in that both lever-
age the same proven technology (Wheatstone bridge) to measure pressure,
connect to the same monitoring cable connector and have a straight ļ¬ow-through
design. The main difference between the two is the shape of the cable. The
ArgoTrans Model 1 has a round cable while the CDX III has a ļ¬at cable.
ArgoTrans Model 2 vs. CDXpress
The ArgoTrans Model 2 is nearly identical to the CDXpress in that both
leverage the same proven technology (Wheatstone bridge) to measure pressure
and connect to the same monitoring cable connector. The main differences are:
ArgoTrans Model 2 CDXpress
Straight, ļ¬owāthrough design 90o elbow ļ¬ow path
Priming device: pull tabs and squeeze wings Priming device: side button
In-housing atmospheric venting Vent in the cable
Completely molded package Flat, semi-rigid cable
Round, pliable cable
4. Argon
Medical Devices
5. Will customers be able to order both the CDX family and the ArgoTrans
family of transducers?
Yes. For the next 90 days, products from both families will be available for pur-
chase to give customers the ability to purchase the current product while they
evaluate the next generation ArgoTrans family of transducers. All custom kits
will be migrated over to the ArgoTrans family of transducers during the same
90-day period.
6. When will the ArgoTrans family of transducers be available?
At the time of announcement, all part numbers will be available for shipment.
7. Will the ArgoTrans family have the same conļ¬gurations as the CDX family?
No. The two CDX models with a Male/Male conļ¬guration will not be available in
an ArgoTrans conļ¬guration. Also, the ArgoTrans has a 60ā cable model.
Safety First Initiative Announcement
8. What is a āSharpsācompliant needle?ā
A Sharpsācompliant needle is a needle that, by design, minimizes the risk of a
clinicianās injury from a needle-stick.
9. What Percutaneous Introducer needle is being announced today?
Argon is announcing a family of Sharpsācompliant, safety introducer needles
called SecureLocā¢ Safety Introducer Needles. These safety introducer needles
feature an āintuitive safety guardā that secures the end of the introducer needle
when it is removed from the patient. The SecureLocā¢ safety introducer needles
will be available in 18, 19 and 21 gauge versions of lengths from 2.0 to 3.5-inch-
es in Seldinger and non-Seldinger conļ¬gurations.
10. When will they be available?
The SecureLocā¢ safety introducer needles will be available from Argon [insert
date]. They will be available as a single-sterile product in quantities of 25 units.
SecureLocā¢ is a trademark of Specialized Health Products, Inc. Ā®
5. Argon
Medical Devices
11. Do clinicians need to learn a new way to perform procedures with SecureLocā¢?
No. SecureLocā¢ is used the same way as a standard introducer needle.
12. What sampling system is being made available today?
Argon is announcing the availability of an addition to its KeepSafeā¢ PTMO prod-
uct family that gives clinicians a needle less, latex-free, Luerāactivated stopcock
from Elcam Medical that is designed to minimize a clinicianās ļ¬uid exposure while
taking a blood sample. With the Luerāactivated, swabable stopcock, the clinician
now has an even safer solution by minimizing the needle-stick and latex expo-
sure risk at the sample site.
13. How is the minimal, residual volume, Luer-activated stopcock (āMarvelousā)
different from the current sample site?
The Marvelous product from Elcam Medical is a latex-free, swabable, Luerāacti-
vated sample site whose design enables automatic ļ¬ushing of the side port and
ļ¬ow lineāzero residual volume. The current sample site is a single-port manifold
that requires a special needle cannula to take a sample. Also, the current sam-
ple site is not latex free. The Marvelous product can also provide a cost savings
over the current product in that there is no additional cannula required.
14. Can customers order the Marvelous separate from a PTMO solution like
KeepSafeā¢?
No. Because of the tight integration of monitoring systems and sampling sys-
tems, the needle less, swabable stopcock will only be available with the purchase
of PTMO solutions like KeepSafeā¢, CDX III, CDXpress or ArgoTrans from
Argon.
15. How will customers integrate the needle less, swabable stopcock with their
KeepSafeā¢ solution?
When the KeepSafeā¢ monitoring solution is being installed, the current sample
site is to be replaced with the latex-free, Luerāactivated stopcock from Elcam. A
standard Luer-based syringe can be used to take the sample.
16. How will the latex-free, Luerāactivated stopcock from Elcam be shipped to
customers?
6. Argon
Medical Devices
The needle less, swabable stopcock will be shipped to customers in single-sterile
packs boxed in quantities of 20 unitsāthe standard quantity for most transducer-
based products.
Announcement
17. What product is being announced?
Argon is announcing an additional model to its already successful line of
Endomyocardial biopsy (EMB) forceps. Responding to cardiologistsā requests for
an extra long (105 cm), FEP coated, straight conļ¬guration forceps, Argon is ex-
tending its line to meet this customer need.
18. When will this new product be available?
The 7F, 105 cm is available at announcement. Its part number is 190086.
Percutaneous Introducer Announcement
19. What percutaneous introducer is being announced today?
Extending the already comprehensive percutaneous introducer line, Argon is
announcing a 98 cm version of its long length, percutaneous introducer product
family. Announced in March of this year, the Access-style long length introducer
family has been very attractive to many Argon customersāhealth care providers
and OEMs.
20. How many sizes are available at announcement?
4 and 5 French sizes are available at announcement. The addition of the 98 cm
models extends the product family from 85 to 98 cm.
7. Argon
Medical Devices
The following tables represent all of the products being announced today by Argon Medical Devices.
Please check with Customer Service for the latest availability of these and all other products from
Argon Medical Devices.
ArgoTrans
Part # of Flush Cable Stopcock Monitoring Arterial IV
Number Transducers Device Length Line Extension System
041516504A 1 14ā
041517504A 1 42ā 1-way
041587505A 1 60ā 1-way
041582505A 1 ā¢ 14ā 4-way 9ā Macro
041595505A 1 ā¢ 14ā 4-way 9ā Micro
041583505A 1 ā¢ 14ā 4-way 48ā 9ā Macro
041584505A 1 ā¢ 14ā 4-way 48ā 9ā Micro
041585505A 1 ā¢ 14ā 4-way 72ā 9ā Macro
041586505A 1 ā¢ 14ā 4-way 72ā 9ā Micro
041589505A 2 ā¢ 14ā (2) 4-way (2) 72ā (2) 12ā Macro
041591505A 3 ā¢ 14ā (3) 4-way (1) Red 72ā (3) 12ā Macro
(1) Blue 48ā
(1) Yellow 48ā
041588505A 1 (Neonatal) ā¢ 14ā (1) double 36ā
Safety First Initiative
KeepSafeā¢ Closed Sampling Systems
Standard kits include: ArgoTrans Model 2 transducer, 14ā cable, 3cc/hr with Steriļ¬oā¢ ļ¬ush device, zero-port
cap, and Macro drip IV system.
Part Number Description (Standard features plus)
041592505 6ā connection tubing, 10cc covered reservoir syringe, 48ā monitoring line, sample site, 1-way
stopcock and 9ā arterial extension.
041593505 6ā connection tubing, 10cc covered reservoir syringe, 72ā monitoring line, sample site, 1-way
stopcock and 9ā arterial extension.
041594505 (2) Additional Model 2 transducers, trifurcated Macro drip IV system, 6ā connection tubing, 10cc
covered reservoir syringe, Red 72ā monitoring line, Blue 48ā monitoring line, Yellow 48ā
monitoring line, sample site, (3) 4-way stopcocks, and (2) 12ā arterial extensions.
8. Argon
Medical Devices
Safety First Initiative
Part Number Description
041240103 Latex free, zero residual volume, Luer-activated, swabable stopcock from Elcam Medical for
PTMO applications requiring needle less access.
S03018-275 18Gx2.75ā SecureLocā¢ Safety arterial needle
S03018-275W 18Gx2.75ā SecureLocā¢ Safety arterial needle with Seldinger Wing
S03018-350 18Gx3.5ā SecureLocā¢ Safety arterial needle
S03019-275 19Gx2.75ā SecureLocā¢ Safety arterial needle
S03021-275 21Gx2.75ā SecureLocā¢ Safety arterial needle
S03021-275W 21Gx2.75ā SecureLocā¢ Safety arterial needle with Seldinger Wing
S03021-200 21Gx2.75ā SecureLocā¢ Safety arterial needle
New and Percutaneous Introducer
Products
Part Number Description
190086 Straight, FEP-coated, 105 cm long EMB forceps. It has a 7-French outer diameter and
requires a 7-French Percutaneous Introducer.
800498 4-French, 98 cm Axcess-style introducer. These Axcess-style percutaneous introducers feature
a long, Luer-locking hub with side port and stopcock. Also, it includes a 175 cm, 0.035ā, double-
ended (straight/3mm J), PTFE guide wire.
800598 5-French, 98 cm Axcess-style introducer. These Axcess-style percutaneous introducers feature
a long, Luer-locking hub with side port and stopcock. Also, it includes a 175 cm, 0.035ā, double-
ended (straight/3mm J), PTFE guide wire.
SecureLocā¢ is a trademark of Specialized Health Products, Inc. Ā®
9. CDX/CDXpress Migration Path
Corresponding ArgoTrans Models
Model 1 Model 2 (w/flush device)
CDX III
41500503 EOL*
41500913 EOL
41513503 00-041516504A
41516503 00-041507504A
New: 60" cable, 1-way
stopcock**: 00-041587505A
CDXpress
41572504 00-041582505A
New: 14" cable, 4-way stopcock**: 00-
041595505A
41574504 00-041583505A
41575504 00-041584505A
41576504 00-041585505A
41577504 00-041586505A
41578504 00-041588505A
41580505 00-041589505A
41581505 00-041591505A
KeepSafe with CDXpress
41574566 00-041592505A
41576566 00-041593505A
41581566 00-041594505A
Comments
*These product codes will be EOL'd at
end of transition period.
**This is a new product/part number. It
will continue after the transition period.
These are new part numbers for the
ArgoTrans corresponding to the
CDX/CDXrpess product on the left.
10. ArgoTrans
Disposable
Blood Pressure Transducers
Experience Innovation
For over 10 years Argon The ArgoTrans transducer
Medical Devices has features a straight ļ¬ow-through
continued to demonstrate an ļ¬uid path. When coupled with
understanding of the monitoring the innovative Universal Steriļ¬oā¢
needs of our critical care ļ¬ush device (Model 2 only),
customers. priming, zeroing and ļ¬ushing the
system is easier than ever.
Proven Design
Functionality
With the ArgoTrans
family of disposable blood The ArgoTrans family
pressure transducers, Argon of transducers has two base
has combined the accuracy
Argon
products: Model 1 and Model
of proven electronics from 2. The Model 1 is a stand-alone
its predecessorāCDX and transducer with cable lengths from
CDXpressāwith a completely 14ā to 60ā. The Model 2 has a
integrated package. larger feature set and is used in
clinical applications requiring more Medical Devices
transducer functionality.
11. Flexibility
With the integral Universal Steriļ¬oā¢ ļ¬ush device, ArgoTrans
transducers give you the ļ¬exibility to ļ¬ush the system as you chooseā
gently pull the tab or squeeze the side wings. Also, they are bundled
with either a Macro or Micro IV drip system for immediate use. Both
IV systems have a 60ā drip line. The Macro ļ¬ows at up to 60 drops/
min. while the Micro ļ¬ows at up to 20 drops/min. For more involved
procedures, bifurcated and trifurcated conļ¬gurations are available.
Part # of Flush Cable Stopcock Monitoring Arterial IV
Number transducers Device Length Line Extension system
041516504 1 14ā
041517504 1 42ā 1-way
041587505 1 60ā 1-way
041582505 1 ā¢ 14ā 4-way 9ā Macro
041583505 1 ā¢ 14ā 4-way 9ā Micro
041584505 1 ā¢ 14ā 4-way 48ā 9ā Macro
041585505 1 ā¢ 14ā 4-way 48ā 9ā Micro
041586505 1 ā¢ 14ā 4-way 72ā 9ā Macro
041587505 1 ā¢ 14ā 4-way 72ā 9ā Micro
041588505 2 ā¢ 14ā (2) 4-way (2) 72ā (1) 9ā, (1) 12ā Macro
041598505 3 ā¢ 14ā (3) 4-way (1) Clear 72ā (1) 9ā, (2) 12ā Macro
(1) Blue 72ā
(1) Yellow 72ā
041591505 1 (Neonatal) ā¢ 14ā (1) double 14ā
KeepSafeā¢ Closed Sampling Systems Safety-First
Standard kits include: ArgoTrans Model 2 transducer, 14ā
cable, 3cc/hr with Steriļ¬oā¢ ļ¬ush device, zero-port cap, and Macro drip OSHA and the CDC have
IV system. demonstrated the cost of injuries
Product Code Description (Standard features plus) resulting from blood-borne pathogens
041592505 6ā connection tubing, 10cc covered reservoir to be very costly. To help customers,
syringe, 48ā monitoring line, sample site, 1-way Argon offers a number of products
stopcock and 9ā arterial extension. designed to support customersā
041593505 6ā connection tubing, 10cc covered reservoir Exposure Control programs.
syringe, 72ā monitoring line, sample site, 1-way
stopcock and 9ā arterial extension. KeepSafeā¢ Closed Sampling System
041594505 (2) Additional Model 2 transducers, kits with ArgoTrans Model 2
trifurcated Macro drip I/V system, 6ā connection Transducers help to minimize the
tubing, 10cc covered reservoir syringe, Red 72ā clinicianās exposure to blood-borne
monitoring line, Blue 48ā monitoring line, Yellow
48ā monitoring line, sample site, (3) 4-way pathogens.
stopcocks, and (2) 12ā arterial extensions.
Argon
Medical Devices
1445 Flat Creek Road Athens, Texas 75751 1-800-927-4669 Fax: 1-903-677-9396 http://www.argonmedical.com
96-6000-13/0607 Argon Medical Devices, Inc. Printed in the U.S.A.
12. ArgoTrans
?
Refer to
IFU
Preparation Mount to the stand
Description
Argon Patient Monitoring (PTMO) Products are stand-alone components, stock kits
or convenience kits built to user speciļ¬cations. Products addressed by this Quick
1 ā¢ Remove trans-
ducer kit from
2 Place transducer on
pole-mount stand.
Set-Up Guide include: monitoring sets, pressure transducers, patient mounted package.
straps, continuous ļ¬ush devices, stopcocks, manifolds, arterial extensions, IV ā¢ Check all
accessories, sample plugs and KeepSafeā¢ Closed Sampling System options. connections and
tighten as neces-
Indications for Use sary.
Argon PTMO products are indicated for physiological pressure measurement,
invasive pressure monitoring, catheterization procedures, infusion of ļ¬uids and/or
obtaining blood or other ļ¬uid samples.
Connect the cables Connect IV line IV preparation Flushing the System
3 ā¢ Connect monitor cable
to transducer.
4 ā¢ Connect IV line to bottom of
transducer.
5 ā¢ Close roller clamp on IV
line
6 With the stopcock in the āUpā po-
sition, ļ¬ush transducer with sa-
ā¢ Rotate the locking ring ā¢ Turn stopcock to āUpā position ā¢ Connect IV spike to sa- line solution by gently squeezing
clock-wise to secure. (off to patient) line solution the wings or pulling the pull tab
ā¢ Loosen Zero-Port cap 1/4 turn. ā¢ Squeeze drip chamber on the front of the transducer.
until chamber is half full.
Pull or Squeeze
Zero Port
Flushing the system Flushing the system Connect to catheter
7 ā¢ Check the IV line and area of the trans-
ducer above the Universal Flush Device to
8 ā¢ Connect the patient monitoring line to
the top of the transducer.
9 Connect the patient monitoring line to
the arterial catheter.
ensure all air has been removed from the ā¢ Turn stopcock 90-degrees clockwise
system. (open to patient line)
ā¢ When saline drips from the Zero Port cap, ā¢ Flush system until air is out of patient
tighten cap. monitoring line
Zero the monitor Measure pressure If you have any questions, please refer to:
10 ā¢ Turn stopcock to āUpā position
(off to the patient)
12 ā¢ Tighten the Zero-Port vent
cap.
ā¢ Instructions for Use (IFU) located in the
shipping carton covers all Warnings,
ā¢ Loosen Zero Port cap 1/4 turn ā¢ Turn the four-way stopcock
Precautions, and Procedures for Use.
ā¢ Zero monitor to manufacturer to the āOnā position (handleās
ā¢ Visit our website:
speciļ¬cations āOffā is positioned over the
http://www.argonmedical.com
transducerās vent port).
ā¢ In the U.S., call Customer Service at:
(800) 9-ARGON-9 or (800) 927-4669
Monday-Friday (7:00am-5:00 PM CST)
ā¢ Your Argon Medical Devices sales representative.
Inļ¬ate pressure bag
11
P/N: 999301580-07/0607
Inļ¬ate pressure bag to
300mmHg.
13. Save this Quick Set-Up Guide for Future Reference
Refer to
ArgoTrans ? IFU
Description Preparation Mount to the stand
Argon Patient Monitoring (PTMO) Products are stand-alone components, stock ā¢ Remove transducer kit Place transducer on pole-
kits or convenience kits built to user speciļ¬cations. Products addressed by
1 from package. 2 mount stand.
this Quick Set-Up Guide include: monitoring sets, pressure transducers, pa- ā¢ Check all connections
tient mounted straps, continuous ļ¬ush devices, stopcocks, manifolds, arterial and tighten as necessary.
extensions, IV accessories, sample plugs and KeepSafeā¢ Closed Sampling
System options.
Indications for Use
Argon PTMO products are indicated for physiological pressure measurement,
invasive pressure monitoring, catheterization procedures, infusion of ļ¬uids
and/or obtaining blood or other ļ¬uid samples.
Contraindications
There are no known contraindications for these products.
Connect the cables Connect IV line IV preparation Flushing the System
ā¢ Connect monitor cable to ā¢ Connect IV line to bottom ā¢ Close roller clamp on IV line With the stopcock in the āUpā
transducer. ā¢ Connect IV spike to saline solution position, ļ¬ush transducer
of transducer.
3 ā¢ Rotate the locking ring
4 ā¢ Turn stopcock to āUpā po-
5 ā¢ Squeeze drip chamber until cham-
ber is half full.
6 with saline solution by gently
clock-wise to secure. sition (off to patient) squeezing the wings or pulling
ā¢ Loosen Zero-Port cap 1/4 the pull tab on the front of the
turn. transducer.
Pull tab Squeeze wings
Zero Port
www.argonmedical.com
P/N: 96-6000-14/0607
14. Save this Quick Set-Up Guide for Future Reference
Refer to
? IFU
ArgoTrans
Flushing the system Flushing the system Connect to catheter Zero the monitor
ā¢ Check the I/V line and area of ā¢ Connect the patient monitoring ā¢ Turn stopcock to the āUpā posi-
the transducer above the Universal
Connect the patient moni-
line to the top of the transducer. tion (off to the patient)
toring line to the arterial
7 Flush Device to ensure all air has
been removed from the system.
8 ā¢ Turn stopcock 90-degrees clock-
9
wise (open to patient line) catheter.
10 ā¢ Loosen Zero Port cap 1/4 turn.
ā¢ Zero monitor to manufacturer
ā¢ When saline drips from the Zero ā¢ Flush system until air is out of pa- speciļ¬cations.
Port cap, tighten cap. tient monitoring line
Inļ¬ate pressure bag Measure pressure If you have any questions,
Inļ¬ate pressure bag to ā¢ Tighten the Zero-Port vent cap. Quick
ā¢ Turn the four-way stopcock to
please refer to:
300 mmHg. ā¢ Instructions for Use (IFU) located
11 12 the āOnā position (handleās āOffā is
positioned over the transducerās in the shipping carton covers all
Set-Up Guide
vent port). Warnings, Precautions, and Pro-
ā¢ Read pressure. cedures for Use. for the
ā¢ Visit our web site:
http://www.argonmedical.com
ā¢ In the U.S., call Customer Service at:
(800) 9-ARGON-9 or (800) 927-4669 ArgoTrans
Monday-Friday (7:00am-5:00pm CST)
ā¢ Your Argon Medical Devices sales
representative.
Patient Monitoring
Products
www.argonmedical.com
P/N: 96-6000-14/0607