Identity
- Trade Name
- MAHURKAR Elite FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
- Device Name
- Acute Dual Lumen Catheter Tray,High Flow Straight Extensions with IC* Safety Components,13.5 Fr/Ch (4.5 mm) x 16 cm FDA UDI
- Model / Reference
- 8888211416 FDA UDI
- Description
- Acute Dual Lumen Catheter Tray,High Flow Straight Extensions with IC* Safety Components,13.5 Fr/Ch (4.5 mm) x 16 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521126015 FDA UDI
- 510(k) Number
- K120674 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
Yes
FDA UDI
Combination Product
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 13.5 French FDA UDILength — 16 Centimeter FDA UDI
Category: Double-lumen haemodialysis catheter, nonimplantable
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 Double-lumen haemodialysis catheter, nonimplantable.
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- DUO-FLOW® — MEDICAL COMPONENTS INC · Class II
- DUO-FLOW® — MEDICAL COMPONENTS INC · Class II
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- ARROW — TELEFLEX INCORPORATED · 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 1515f973-43bb-4a1d-9803-2de8a8827e10 36 fields · synced Jun 8, 2026