ICU Medical

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: ICU Medical FDA UDI
Generic Name: Blood transfusion set, non-exchange FDA UDI
Device Name: 136" (345 cm) Bifuse 10 Drop Blood Set w/2 MicroClave™ Clear, 170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way NanoClave™ Stopcock, Rotating Luer, 2 Ext FDA UDI
Model / Reference: AC228 FDA UDI
Description: 136" (345 cm) Bifuse 10 Drop Blood Set w/2 MicroClave™ Clear, 170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way NanoClave™ Stopcock, Rotating Luer, 2 Ext FDA UDI

Identifiers

Catalog Number: AC228 FDA UDI
Primary DI / UDI-DI: 00887709090583 FDA UDI
510(k) Number: K964435 FDA UDI
FDA Product Code: FMG FDA UDI
GMDN Term: Blood transfusion set, non-exchange FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5440 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Blood transfusion set, non-exchange

ICU Medical by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Walrus — CODAN US Corporation · Class II
Walrus — CODAN US Corporation · Class II

Cleared under the same submission

K964435 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Icu Medical, Inc.

Sources (1)

FDA UDI fc568113-19cf-40d5-a146-cfd3c3691f88 36 fields · synced May 30, 2026