MediChoice

FDA UDI

Class I (US FDA UDI)

by Owens & Minor Distribution, Inc.

Identity

Trade Name: MediChoice FDA UDI
Generic Name: Anaesthesia face mask, single-use FDA UDI
Device Name: Mask Anesthesia With Hook Ring Inflation Valve Adult Large Non-Sterile Not Made With Natural Rubber Latex MediChoice FDA UDI
Model / Reference: AM1000 FDA UDI
Description: Mask Anesthesia With Hook Ring Inflation Valve Adult Large Non-Sterile Not Made With Natural Rubber Latex MediChoice FDA UDI

Identifiers

Primary DI / UDI-DI: 10885632107146 FDA UDI
FDA Product Code: BSJ FDA UDI
GMDN Term: Anaesthesia face mask, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5550 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Anaesthesia face mask, single-use

MediChoice by Owens & Minor Distribution, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia face mask, single-use.

Ventlab — Ventlab Corp. · Class I
Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant — Dynarex Corp. · Class I
Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
Vital Signs™ — Airlife, Inc. · Class I
Ventlab — Ventlab Corp. · Class I
Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
King Mask — Ambu A/S · Class I

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: Owens & Minor Distribution, Inc.

Sources (1)

FDA UDI d6bfe8e1-6733-4329-8405-deb30e2976d8 33 fields · synced May 31, 2026