Identity
- Trade Name
- MAHURKAR Elite FDA UDI
- Generic Name
- Triple-lumen haemodialysis catheter FDA UDI
- Device Name
- Acute Triple Lumen Catheter Kit Straight Extensions FDA UDI
- Model / Reference
- 8888231216 FDA UDI
- Description
- Acute Triple Lumen Catheter Kit Straight Extensions FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521126947 FDA UDI
- 510(k) Number
- K120674 FDA UDI
- FDA Product Code
- NIE FDA UDI
- GMDN Term
- Triple-lumen haemodialysis catheter 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
Yes
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 — 16 Centimeter FDA UDICatheter Gauge — 12.5 French FDA UDI
Category: Triple-lumen haemodialysis catheter
MAHURKAR Elite by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Triple-lumen haemodialysis catheter.
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- Power-Trialysis catheter — Bard Access Systems, Inc. · Class II
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Cleared under the same submission
K120674 also covers:
- MAHURKAR Elite — Mozarc Medical US LLC
- MAHURKAR Elite — Mozarc Medical US LLC
- MAHURKAR Elite — Mozarc Medical US LLC
- MAHURKAR Elite — Mozarc Medical US LLC
- MAHURKAR Elite — Mozarc Medical US LLC
- MAHURKAR Elite — Mozarc Medical US LLC
- MAHURKAR Elite — Mozarc Medical US LLC
- MAHURKAR Elite — Mozarc Medical US LLC
- MAHURKAR Elite — Mozarc Medical US LLC
- MAHURKAR Elite — Mozarc Medical US LLC
- MAHURKAR Elite — Mozarc Medical US LLC
- MAHURKAR Elite — Mozarc Medical US LLC
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
- Mozarc Medical US LLC
Sources (1)
- FDA UDI 9eab371d-70e8-4634-8952-fd06c1fd248c 36 fields · synced Jun 8, 2026