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GamCath HighFlow Dolphin Catheter
FDA UDIClass II (US FDA UDI)
by Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
Identity
- Trade Name
- GamCath HighFlow Dolphin Catheter FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
- Device Name
- Short-term use to obtain vasular access in patients with acute or chronic renal failure. The GamCath HighFlow Dolphin Catheter combines the GamCath HighFlow Catheter with an additional coating based on a block copolymer. FDA UDI
- Model / Reference
- GAMCATH MS-GDHC-1115 A FDA UDI
- Description
- Short-term use to obtain vasular access in patients with acute or chronic renal failure. The GamCath HighFlow Dolphin Catheter combines the GamCath HighFlow Catheter with an additional coating based on a block copolymer. FDA UDI
Identifiers
- Catalog Number
- 114022 FDA UDI
- Primary DI / UDI-DI
- 07332414110666 FDA UDI
- 510(k) Number
- K100451 FDA UDI
- FDA Product Code
- MPB FDA UDI
- GMDN Term
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5540 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 150 Millimeter FDA UDICatheter Gauge — 11.5 French FDA UDI
Category: Double-lumen haemodialysis catheter, nonimplantable
GamCath HighFlow Dolphin Catheter by Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH — Class II — FDA UDI — listed in FDA…
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Cleared under the same submission
K100451 also covers:
- GamCath HighFlow Dolphin Catheter — Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
- GamCath HighFlow Dolphin Catheter — Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
- GamCath HighFlow Dolphin Catheter — Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
- GamCath HighFlow Dolphin Catheter — Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
- GamCath HighFlow Dolphin Catheter — Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
- GamCath HighFlow Dolphin Catheter — Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
- GamCath HighFlow Dolphin Catheter — Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
- GamCath HighFlow Dolphin Catheter — Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
- GamCath HighFlow Dolphin Catheter — Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
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
Sources (1)
- FDA UDI afe0600b-0d2a-4a87-8cb5-50441862c7cf 38 fields · synced May 30, 2026