Gyrus ACMI

FDA UDI

Class I (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: Gyrus ACMI FDA UDI
Generic Name: Stopcock FDA UDI
Device Name: Universal Stopcock Adapter Luer Lock FDA UDI
Model / Reference: 75U FDA UDI
Description: Universal Stopcock Adapter Luer Lock FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925007321 FDA UDI
510(k) Number: K883819 FDA UDI
FDA Product Code: CCW FDA UDI
GMDN Term: Stopcock FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Stopcock

Gyrus ACMI by Gyrus Acmi, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stopcock.

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NAMIC — NAVILYST MEDICAL, INC. · Class I
Q2 High Flow Stopcock — QUEST MEDICAL INC · Class II
NAMIC — MEDLINE INDUSTRIES, INC. · Class II
NAMIC — NAVILYST MEDICAL, INC. · Class II
Demax — Beijing Demax Medical Technology Co., Ltd · Class II
NAMIC — MEDLINE INDUSTRIES, INC. · Class II

Cleared under the same submission

K883819 also covers:

Gyrus ACMI — Gyrus Acmi, 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 I	Pending data

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Manufacturer

Manufacturer: Gyrus Acmi, Inc.

Sources (1)

FDA UDI 74d07694-7629-49fa-b654-03a405bf6736 34 fields · synced Jun 6, 2026