Identity
- Trade Name
- GAMCATH TRAY FDA UDI
- Generic Name
- Haemodialysis catheterization kit FDA UDI
- Device Name
- The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies for insertion of the catheter. FDA UDI
- Model / Reference
- GAMHRVA01A FDA UDI
- Description
- The GAMCATH Insertion Tray is a convenience kit which includes a GAMCATH catheter and supplies for insertion of the catheter. FDA UDI
Identifiers
- Catalog Number
- MSGDHC1120A FDA UDI
- Primary DI / UDI-DI
- 05413765500220 FDA UDI
- FDA Product Code
- PEV FDA UDI
- GMDN Term
- Haemodialysis catheterization kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 11.5 French FDA UDILength — 200 Millimeter FDA UDI
Category: Haemodialysis catheterization kit
Gamcath Tray by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis catheterization kit.
- Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*20cm(Straight) — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set Double Lumen12F*16cm(Straight) — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set Double Lumen12F*16cm(Straight) — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Baxter International Inc.
Sources (1)
- FDA UDI f9f97c5f-a4ba-4a52-a69f-eb0c4c3f38d2 37 fields · synced Jun 8, 2026