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Hemo-Cath®

FDA UDI

Class II (US FDA UDI)

by Medical Components Inc

Identity

Trade Name
HEMO-CATH® FDA UDI
Generic Name
Double-lumen haemodialysis catheter, implantable FDA UDI
Device Name
12.5F X 15CM HEMO-CATH® SILICONE DOUBLE LUMENSILICONE DO BASIC SETBASIC SET (CUFF 10CM FROM TIP)(CUFF 10CM F FDA UDI
Model / Reference
DMC101241 FDA UDI
Description
12.5F X 15CM HEMO-CATH® SILICONE DOUBLE LUMENSILICONE DO BASIC SETBASIC SET (CUFF 10CM FROM TIP)(CUFF 10CM F FDA UDI

Identifiers

Catalog Number
DMC101241 FDA UDI
Primary DI / UDI-DI
00884908140811 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
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

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

Category: Double-lumen haemodialysis catheter, implantable

Hemo-Cath® by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Double-lumen haemodialysis catheter, implantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Components Inc

Sources (1)

  • FDA UDI 2e8f7a4e-c64d-4672-8a8d-0b8b651fbdfc 35 fields · synced Jun 1, 2026