ICU Medical

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: ICU Medical FDA UDI
Generic Name: Fluid transfer set, general-purpose FDA UDI
Device Name: 111" (282 cm) Appx 7.8 ml, Transfer Set w/MicroClave® Clear, Dual Check Valve, Smallbore Quadfuse Ext Set w/MicroClave® Clear, 5 Clamps (2 Red, Blue, 2 White), Rotating Luer FDA UDI
Model / Reference: MC330160 FDA UDI
Description: 111" (282 cm) Appx 7.8 ml, Transfer Set w/MicroClave® Clear, Dual Check Valve, Smallbore Quadfuse Ext Set w/MicroClave® Clear, 5 Clamps (2 Red, Blue, 2 White), Rotating Luer FDA UDI

Identifiers

Catalog Number: MC330160 FDA UDI
Primary DI / UDI-DI: 00887709079007 FDA UDI
510(k) Number: K964435 FDA UDI
FDA Product Code: FMG FDA UDI
GMDN Term: Fluid transfer set, general-purpose 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: Fluid transfer set, general-purpose

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

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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 771cfb47-f42a-4f0e-b1cb-a2929c4fcab9 36 fields · synced May 30, 2026