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Hemo-Flow®

FDA UDI

Class II (US FDA UDI)

by Medical Components Inc

Identity

Trade Name
Hemo-Flow® FDA UDI
Generic Name
Double-lumen haemodialysis catheter, implantable FDA UDI
Device Name
14.5F X 32CM PRE-CURVED HEMO-FLOW® DOUBLE LUMEN CATHETER SET (CUFF 27CM FROM TIP) FDA UDI
Model / Reference
HFS32PC FDA UDI
Description
14.5F X 32CM PRE-CURVED HEMO-FLOW® DOUBLE LUMEN CATHETER SET (CUFF 27CM FROM TIP) FDA UDI

Identifiers

Catalog Number
HFS32PC FDA UDI
Primary DI / UDI-DI
00884908130508 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
MRI Safety
MR Safe FDA UDI

Category: Double-lumen haemodialysis catheter, implantable

Hemo-Flow® 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 dc32c0b4-f5d5-49bf-b5f4-b5ceb109613b 35 fields · synced Jun 1, 2026