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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
120" (305 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 4 Clave®, Rotating Luer w/Filter Cap, 1 Ext FDA UDI
Model / Reference
Z0916 FDA UDI
Description
120" (305 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 4 Clave®, Rotating Luer w/Filter Cap, 1 Ext FDA UDI

Identifiers

Primary DI / UDI-DI
00887709022072 FDA UDI
FDA Product Code
FJK FDA UDI
GMDN Term
Blood transfusion set, non-exchange 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

No

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

Category: Blood transfusion set, non-exchange

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

Similar devices

Also classified as Blood transfusion set, non-exchange.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI 01546020-adce-4833-9b91-2cabf75cdcd9 33 fields · synced May 30, 2026