← Back to catalogue

Mahurkar

FDA UDI

Class II (US FDA UDI)

by Mozarc Medical US LLC

Identity

Trade Name
MAHURKAR FDA UDI
Generic Name
Double-lumen haemodialysis catheter, nonimplantable FDA UDI
Device Name
Acute Dual Lumen Catheter Tray High Flow Straight Extensions with IC Components FDA UDI
Model / Reference
8888135139 FDA UDI
Description
Acute Dual Lumen Catheter Tray High Flow Straight Extensions with IC Components FDA UDI

Identifiers

Primary DI / UDI-DI
10884521058378 FDA UDI
510(k) Number
K030209 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
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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 13.5 Centimeter FDA UDI
Catheter Gauge — 13.5 French FDA UDI

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

Cleared under the same submission

K030209 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mozarc Medical US LLC

Sources (1)

  • FDA UDI 36c2f2a9-0be5-44f2-8e1c-f759c3d986fe 38 fields · synced Jun 8, 2026