ICU Medical

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: ICU Medical FDA UDI
Generic Name: Vial/bottle adaptor, non-hermetic FDA UDI
Device Name: Universal Vented Vial Spike, Clave™ FDA UDI
Model / Reference: CH-51 FDA UDI
Description: Universal Vented Vial Spike, Clave™ FDA UDI

Identifiers

Catalog Number: CH-51 FDA UDI
Primary DI / UDI-DI: 00840619025779 FDA UDI
510(k) Number: K080989 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Vial/bottle adaptor, non-hermetic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 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: Vial/bottle adaptor, non-hermetic

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

Similar devices

Also classified as Vial/bottle adaptor, non-hermetic.

Curaplex — BOUND TREE MEDICAL, LLC · Class II
Vial Adapter — WEST PHARMA. SERVICES IL, . LTD · Class II
Vial Adapter — WEST PHARMA. SERVICES IL, . LTD · Class II
Mini-Spike® — B. BRAUN MEDICAL INC. · Class II
VYGON — Vygon Corp. · Class II
ViaLok — Yukon Medical, LLC · Class II
ZYNRELEF 20 mL Vial Access Needle (VAN) — HERON THERAPEUTICS, INC.
Vial Adaptor — WEST PHARMA. SERVICES IL, . LTD · Class II

Cleared under the same submission

K080989 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 1ab04a24-8702-4cbb-ab3d-cf882ee44231 36 fields · synced May 30, 2026