SuperNO2VA

FDA UDI

Class II (US FDA UDI)

by Airlife, Inc.

Identity

Trade Name: SuperNO2VA FDA UDI
Generic Name: CPAP/BPAP nasal mask, single-use FDA UDI
Device Name: SuperNO2VA Et Mask, Adult Medium FDA UDI
Model / Reference: SEM-20-CE FDA UDI
Description: SuperNO2VA Et Mask, Adult Medium FDA UDI

Identifiers

Catalog Number: SEM-20-CE FDA UDI
Primary DI / UDI-DI: 10889483605691 FDA UDI
510(k) Number: K173147 FDA UDI
FDA Product Code: CCK FDA UDI
BSJ FDA UDI
GMDN Term: CPAP/BPAP nasal mask, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1400 FDA UDI
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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: CPAP/BPAP nasal mask, single-use

SuperNO2VA by Airlife, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CPAP/BPAP nasal mask, single-use.

BiTrac Vented — Pulmodyne Inc. · Class II
PN841 — Respironics, Inc. · Class II
Flow-Safe II Disposable CPAP System — MERCURY ENTERPRISES, INC. · Class II
PN841 — Respironics, Inc. · Class II
BiTrac HC — Pulmodyne Inc. · Class II
FitStar Hospital Nasal Non Vented Mask, s/m — Sleepnet Corporation · Class II
Whisper Soft — Engineered Medical Systems, LLC · Class II
BiTrac — Pulmodyne Inc. · Class II

Cleared under the same submission

K173147 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Airlife, Inc.

Sources (1)

FDA UDI d27f8da5-6f90-4e34-8915-45e8d5762c01 37 fields · synced Jun 1, 2026