Asp Medical

FDA UDI

Class I (US FDA UDI)

by Asp Global, LLC

Identity

Trade Name: ASP MEDICAL FDA UDI
Generic Name: Non-rebreathing oxygen face mask FDA UDI
Device Name: DISPOSABLE AIR CUSHION MASK, VALVE ON TOP, SIZE 2, 1/EA FDA UDI
Model / Reference: MAT112 FDA UDI
Description: DISPOSABLE AIR CUSHION MASK, VALVE ON TOP, SIZE 2, 1/EA FDA UDI

Identifiers

Primary DI / UDI-DI: 00840216103580 FDA UDI
FDA Product Code: BSJ FDA UDI
GMDN Term: Non-rebreathing oxygen face mask 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

Yes

FDA UDI

Prescription Use

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

Category: Non-rebreathing oxygen face mask

Asp Medical by Asp Global, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-rebreathing oxygen face mask.

POM EZ-Lite — Stryker Corp. · Class II
BF — Allied Medical LLC · Class I
Rescuer O-Mask — B.L.S. Systems Limited · Class I
Resp-O2 Oxygen Mask High-Concentration, Elongated Adult — Dynarex Corp. · Class I
BF — Allied Medical LLC · Class I
Procedural Oxygen Mask — Stryker Corp. · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class I
Ventlab — Ventlab Corp. · 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: Asp Global, LLC

Sources (1)

FDA UDI ce114319-dffc-4555-8c18-adc3b809b2d9 33 fields · synced May 30, 2026