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Hemoflow™

FDA UDI

Class II (US FDA UDI)

by Fresenius Medical Care Holdings, Inc.

Identity

Trade Name
Hemoflow™ FDA UDI
Generic Name
Hollow-fibre haemodialysis dialyser, single-use FDA UDI
Device Name
F3 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.3 m2 / ETO / Low Volume / Single Use / 26 mL FDA UDI
Model / Reference
0520165A FDA UDI
Description
F3 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.3 m2 / ETO / Low Volume / Single Use / 26 mL FDA UDI

Identifiers

Primary DI / UDI-DI
00840861100019 FDA UDI
FDA Product Code
FJI FDA UDI
GMDN Term
Hollow-fibre haemodialysis dialyser, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5820 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

No

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

Dimensions & Sizes

Size
Area/Surface Area — 0.4 Square meter FDA UDI
Area/Surface Area — 0.3 Square meter FDA UDI

Category: Hollow-fibre haemodialysis dialyser, single-use

Hemoflow™ by Fresenius Medical Care Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hollow-fibre haemodialysis dialyser, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fresenius Medical Care Holdings, Inc.

Sources (1)

  • FDA UDI 702312f4-d0d2-4c08-b213-da644813e133 36 fields · synced May 30, 2026