DEVICE: GAMCATH TRAY (05413765500299)
Device Identifier (DI) Information
GAMCATH TRAY
GAMHRVA05A
In Commercial Distribution
MSGDHC1325A
BAXTER INTERNATIONAL INC.
GAMHRVA05A
In Commercial Distribution
MSGDHC1325A
BAXTER INTERNATIONAL INC.
The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies for insertion of the catheter.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
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PEV | Dialysis administration kits (convenience kit) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 |
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Length: 250 Millimeter |
Catheter Gauge: 13 French |
Device Size Text, specify: STRAIGHT |
Device Record Status
beac6fe3-433e-4772-9396-052e65c0c5ee
March 29, 2018
2
November 10, 2015
March 29, 2018
2
November 10, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
55413765500294 | 5 | 05413765500299 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
medinfo_medproducts@baxter.com
medinfo_medproducts@baxter.com