Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004450998

FEI Number

3004450998

Entity Name

Gyrus ACMI, Inc.

City/State/Country

Redmond, WA, US

Establishment Address

6675 185th Avenue NE, Redmond, WA 98052, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OLYMPUS CORPORATION (Owner Number: 9067818)

Owner / Operator Contact Address

2951 ISHIKAWA-CHO, HACHIOJI-SHI, JP-13 192-8507, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

H060002

All Registered Proprietary Names

IBV Valve

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAZ	One-Way Air-Leak Valve	Unknown	Class f	N/A	2010-08-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OLYMPUS CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007389669	Algram Group Ltd	Plymouth Devon, GB
9611174	KEYMED (Medical & Industrial Equipment) Ltd	SOUTHEND-ON-SEA Essex, GB
3010590422	QUEST MEDICAL IMAGING	Wieringerwerf Noord-Holland, NL
3031983124	ODIN MEDICAL LIMITED	London London, City of, GB
3003724334	Olympus Winter & Ibe GmbH	TELTOW Brandenburg, DE

Similar Registrations

Registration Number	Establishment Name	Location
3003790304	GYRUS ACMI, INC.	Westborough, MA, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
3027386225	ENTERRA MEDICAL, INC.	Saint Louis Park, MN, US
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL
8031561	NIKKISO CO., LTD. - SHIZUOKA PLANT	SHIZUOKA-KEN, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004450998. Last updated year: 2026. Please use registration number 3004450998 when referencing this establishment in official correspondence.