DEVICE: GAMCATH TRAY (05413765500244)

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Device Identifier (DI) Information

GAMCATH TRAY
GAMHRVA09A
MSGDHC1125A
BAXTER INTERNATIONAL INC.
05413765500244
GS1
1
The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies for insertion of the catheter.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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No
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Yes
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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
Haemodialysis catheterization kit A collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access 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 includes a nonimplantable double-lumen haemodialysis catheter, device dedicated to catheter introduction/function (e.g., introducer needle, guidewire) and includes non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
PEV Dialysis administration kits (convenience kit)
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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: between 59 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 250 Millimeter
Catheter Gauge: 11.5 French
Device Size Text, specify: STRAIGHT
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Device Status

In Commercial Distribution
November 10, 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
55413765500249 5 05413765500244 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
Yes
No CLOSE

Customer Contact

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