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Duo-Flow®

FDA UDI

Class II (US FDA UDI)

by Medical Components Inc

Identity

Trade Name
DUO-FLOW® FDA UDI
Generic Name
Double-lumen haemodialysis catheter, nonimplantable FDA UDI
Device Name
12FX20CM DUO-FLOW ® SIDE X SIDE DOUBLE LUMEN CATHETER W/CURVED EXTENSIONS BASIC SET FDA UDI
Model / Reference
AC0912201 FDA UDI
Description
12FX20CM DUO-FLOW ® SIDE X SIDE DOUBLE LUMEN CATHETER W/CURVED EXTENSIONS BASIC SET FDA UDI

Identifiers

Catalog Number
AC0912201 FDA UDI
Primary DI / UDI-DI
00884908136975 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
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

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, nonimplantable

Duo-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, nonimplantable.

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 09d1c612-59c9-4f16-877f-ff74b51bde98 35 fields · synced May 30, 2026