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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, implantable FDA UDI
Device Name
Acute Dual Lumen Catheter Tray High Flow Straight Extensions with IC Components FDA UDI
Model / Reference
8888145255 FDA UDI
Description
Acute Dual Lumen Catheter Tray High Flow Straight Extensions with IC Components FDA UDI

Identifiers

Catalog Number
8888145255 FDA UDI
Primary DI / UDI-DI
10884521014343 FDA UDI
510(k) Number
K111372 FDA UDI
FDA Product Code
MSD FDA UDI
GMDN Term
Double-lumen haemodialysis catheter, implantable 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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
Catheter Gauge — 14.5 French FDA UDI
Length — 19 Centimeter 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

K111372 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mozarc Medical US LLC

Sources (1)

  • FDA UDI 64ae0fd8-3c63-4cc4-8e10-def1e3f10951 39 fields · synced Jun 8, 2026