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Mahurkar
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 8830414001Model Mahurkar Acute Dual Lumen Catheter
Identity
- Trade Name
- MAHURKAR™Acute Dual Lumen Catheter Straight Extensions with 2 Sealing Caps11.5 Fr/Ch (3.8 mm) x 16 cm EUDAMEDMAHURKAR FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
- Device Name
- MAHURKAR™Acute Dual Lumen Catheter Straight Extensions with 2 Sealing Caps11.5 Fr/Ch (3.8 mm) x 16 cm EUDAMEDAcute Dual Lumen Catheter,Straight Extensions with 2 Sealing Caps FDA UDI
- Model / Reference
- 8830414001 EUDAMEDFDA UDIMahurkar Acute Dual Lumen Catheter EUDAMED
- Description
- Acute Dual Lumen Catheter,Straight Extensions with 2 Sealing Caps FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20884521005126 EUDAMED10884521005129 FDA UDI
- Basic UDI-DI
- B-20884521005126 EUDAMED
- FDA Product Code
- FOZ FDA UDI
- EMDN Code
- F900201 TEMPORARY HEMODIALYSIS CATHETERS AND KITS EUDAMED
- GMDN Term
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — 16 Centimeter FDA UDICatheter Gauge — 11.5 French FDA UDI
Category: Double-lumen haemodialysis catheter, nonimplantable
Mahurkar by Mozarc Medical US LLC — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mozarc Medical US LLC
Sources (2)
- FDA UDI 1609d94e-0615-414c-830f-2e71ebba806a 35 fields · synced Oct 7, 2026
- EUDAMED 72f5cb15-ec4e-454c-aafa-e7ee2ebbc82d 61 fields · synced Oct 7, 2026