Medex

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Medex FDA UDI
Generic Name: In-line backflow valve, single-use FDA UDI
Model / Reference: SM5003 FDA UDI

Identifiers

Primary DI / UDI-DI: 10351688500656 FDA UDI
510(k) Number: K943897 FDA UDI
FDA Product Code: FPA FDA UDI
GMDN Term: In-line backflow valve, single-use 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: In-line backflow valve, single-use

Medex 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

K943897 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 ca542375-bfab-4a7b-8112-ad2cf2151068 33 fields · synced May 30, 2026