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 Tray Curved Extensions with IC Components FDA UDI
Model / Reference: 8888102003HP FDA UDI
Description: Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components FDA UDI

Identifiers

Primary DI / UDI-DI: 30884521127993 FDA UDI
510(k) Number: K102605 FDA UDI
K192302 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

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 20 Centimeter FDA UDI
Catheter Gauge — 12 French 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

Cleared under the same submission

K102605 also covers:

MAHURKAR — Mozarc Medical US LLC
MAHURKAR — Mozarc Medical US LLC

K192302 also covers:

MAHURKAR — Mozarc Medical US LLC
MAHURKAR — 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 09f5ba70-2f4d-4224-b3d4-7585cdfdb3aa 37 fields · synced Jun 8, 2026