DEVICE: GamCath HighFlow Dolphin Catheter (07332414110710)

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Device Identifier (DI) Information

GamCath HighFlow Dolphin Catheter
GAMCATH MS-GDHC-1325 A
114027
Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
07332414110710
GS1
1
Short-term use to obtain vasular access in patients with acute or chronic renal failure. The GamCath HighFlow Dolphin Catheter combines the GamCath HighFlow Catheter with an additional coating based on a block copolymer.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Double-lumen haemodialysis catheter, nonimplantable A sterile, flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MPB CATHETER, HEMODIALYSIS, NON-IMPLANTED
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: less than 30 Degrees Celsius
Special Storage Condition, Specify: Keep dry. Keep away from sunlight.
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Clinically Relevant Size

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Size Type Text
Length: 250 Millimeter
Catheter Gauge: 13 French
Device Size Text, specify: STRAIGHT
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Device Status

In Commercial Distribution
October 07, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
37332414110711 5 07332414110710 In Commercial Distribution CASE
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(800)933-0303
Medinfo_medproducts@baxter.com
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