AccessGUDID - DEVICE: GAMCATH TRAY (05413765500299)

GUDID

Device Identifier (DI) Information

Brand Name: GAMCATH TRAY
Version or Model: GAMHRVA05A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MSGDHC1325A
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 05413765500299
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies for insertion of the catheter.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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
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.

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.

FDA Product Code

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Product Code	Product Code Name
PEV	Dialysis administration kits (convenience kit)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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 .

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: beac6fe3-433e-4772-9396-052e65c0c5ee
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 10, 2015