ICU Medical

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: ICU Medical FDA UDI
Generic Name: Cardiac catheterization monitoring system FDA UDI
Device Name: Optical Module, Refurbished FDA UDI
Model / Reference: 50131-14 FDA UDI
Description: Optical Module, Refurbished FDA UDI

Identifiers

Catalog Number: 50131-14 FDA UDI
Primary DI / UDI-DI: 00840619085636 FDA UDI
510(k) Number: K152006 FDA UDI
FDA Product Code: DQA FDA UDI
GMDN Term: Cardiac catheterization monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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: Cardiac catheterization monitoring system

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

K152006 also covers:

ICU Medical — ICU MEDICAL FLEET SERVICES, LLC
ICU Medical — ICU MEDICAL, INC.
ICU Medical — ICU MEDICAL, INC.
ICU Medical — ICU MEDICAL, INC.

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 c8f12bdb-dcb8-4653-a9eb-bb5089649374 36 fields · synced Jun 8, 2026