ICU Medical

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: ICU Medical FDA UDI
Generic Name: Luer-formatted disinfection cap FDA UDI
Device Name: CAP, STERILE FDA UDI
Model / Reference: CAP-1 FDA UDI
Description: CAP, STERILE FDA UDI

Identifiers

Primary DI / UDI-DI: 00840619046095 FDA UDI
510(k) Number: K964435 FDA UDI
FDA Product Code: FMG FDA UDI
GMDN Term: Luer-formatted disinfection cap 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

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: Luer-formatted disinfection cap

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

Similar devices

Also classified as Luer-formatted disinfection cap.

RPC — Reprocessing Products Corp · Class I
3M™ Curos™ — 3M COMPANY · U
Curos Tips™ — 3M COMPANY · U
Curos Jet™ — 3M COMPANY · U
Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
Molded Products, Inc. — MOLDED PRODUCTS INC. · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Icu Medical, Inc.

Sources (1)

FDA UDI 52e5f7a8-54ad-4546-8f04-071719608b73 34 fields · synced Jun 6, 2026