DEVICE: GAMCATH TRAY (05413765500237)

Device Identifier (DI) Information

GAMCATH TRAY
GAMHRVA02A
In Commercial Distribution
MSGDHC1120JA
BAXTER INTERNATIONAL INC.
05413765500237
GS1

1
005146311 *Terms of Use
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
Yes
No
Yes
Yes
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60879 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PEV Dialysis administration kits (convenience kit)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Store at Controlled Room Temperature. Avoid contact with an open flame or high intensity heat sources .
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Catheter Gauge: 11.5 French
Length: 200 Millimeter
Device Size Text, specify: CURVED
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Device Record Status

822e4da6-4f97-4359-80d5-e95c054709df
July 20, 2023
4
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
55413765500232 5 05413765500237 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

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