Disposable Air Cushion Mask Size#2 Child

FDA UDIEUDAMED

Class I (US FDA UDI)

by Besmed Health Business Corp.

Identity

Trade Name: DISPOSABLE AIR CUSHION MASK SIZE#2 CHILD FDA UDI
Generic Name: Anaesthesia face mask, single-use FDA UDI
Device Name: DISPOSABLE AIR CUSHION MASK SIZE#2 CHILD FDA UDI
Model / Reference: CM-65121 FDA UDI
Description: DISPOSABLE AIR CUSHION MASK SIZE#2 CHILD FDA UDI

Identifiers

Primary DI / UDI-DI: 04716770651217 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Anaesthesia face mask, single-use

Disposable Air Cushion Mask Size#2 Child by Besmed Health Business Corp. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Besmed Health Business Corp.

Sources (2)

FDA UDI 90eea334-0e3e-44ac-9d6b-3b2f3b5680d8 33 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 3, 2026