Datex-Ohmeda

FDA UDI

Class I (US FDA UDI)

by Western Enterprises, Inc.

Identity

Trade Name: DATEX-OHMEDA FDA UDI
Generic Name: Pin-indexed adaptor, reusable FDA UDI
Device Name: 1009-3036-000/ M91-4 PVT LABEL FDA UDI
Model / Reference: OMA-8652 FDA UDI
Description: 1009-3036-000/ M91-4 PVT LABEL FDA UDI

Identifiers

Catalog Number: OMA-8652 FDA UDI
Primary DI / UDI-DI: B929OMA86520 FDA UDI
FDA Product Code: CAM FDA UDI
GMDN Term: Pin-indexed adaptor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.6885 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Pin-indexed adaptor, reusable

Datex-Ohmeda by Western Enterprises, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Western Enterprises, Inc.

Sources (1)

FDA UDI 7949c862-da9f-402b-8c29-9cd38fc9ff7e 34 fields · synced Jun 8, 2026