Identity
- Trade Name
- MAHURKAR FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
- Device Name
- Acute Dual Lumen Catheter Kit,Pre-Curved,11.5 Fr/Ch (3.8 mm) x 13.5 cm FDA UDI
- Model / Reference
- 8888115132 FDA UDI
- Description
- Acute Dual Lumen Catheter Kit,Pre-Curved,11.5 Fr/Ch (3.8 mm) x 13.5 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521005396 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- GMDN Term
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Commercial Distribution
- Not 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 — 13.5 Centimeter FDA UDICatheter Gauge — 11.5 French FDA UDI
Mahurkar by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mozarc Medical US LLC
Sources (1)
- FDA UDI 00a856a5-2846-495b-9872-12f20ad92645 37 fields · synced Jun 8, 2026