Mahurkar

FDA UDI

Class II (US FDA UDI)

by Mozarc Medical US LLC

Identity

Trade Name: MAHURKAR FDA UDI
Generic Name: Triple-lumen haemodialysis catheter FDA UDI
Device Name: Acute High Pressure Triple Lumen Catheter,Curved Extensions FDA UDI
Model / Reference: 8888345538HP FDA UDI
Description: Acute High Pressure Triple Lumen Catheter,Curved Extensions FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521128125 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 12 French FDA UDI
Length — 24 Centimeter FDA UDI

Category: Triple-lumen haemodialysis catheter

Mahurkar by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Triple-lumen haemodialysis catheter.

T-3T-3 — MEDICAL COMPONENTS INC · Class II
TRIO-CT® — MEDICAL COMPONENTS INC · Class II
Power-Trialysis catheter — Bard Access Systems, Inc. · Class II
Power-Trialysis catheter — Bard Access Systems, Inc. · Class II
TRIO-CT® — MEDICAL COMPONENTS INC · Class II
TRIO-CT® — MEDICAL COMPONENTS INC · Class II
TRIO-CT® — MEDICAL COMPONENTS INC · Class II
TRIO-CT® — MEDICAL COMPONENTS INC · Class II

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 b8708f80-80f3-4335-b7e9-74e4a70fc050 35 fields · synced Jun 8, 2026