miniFlow

FDA UDI

Class II (US FDA UDI)

by Airon Corporation

Identity

Trade Name: miniFlow FDA UDI
Generic Name: CPAP/BPAP nasal mask, single-use FDA UDI
Device Name: miniFlow Nasal Mask, size small, single patient use each. FDA UDI
Model / Reference: 58408 FDA UDI
Description: miniFlow Nasal Mask, size small, single patient use each. FDA UDI

Identifiers

Catalog Number: 58408 FDA UDI
Primary DI / UDI-DI: 00853678006214 FDA UDI
510(k) Number: K121379 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: CPAP/BPAP nasal mask, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 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

Yes

FDA UDI

Dimensions & Sizes

Size: Height — .50 Inch FDA UDI
Width — 1.0 Inch FDA UDI
Length — 2.5 Inch FDA UDI
Weight — .018 Pound FDA UDI

Category: CPAP/BPAP nasal mask, single-use

miniFlow by Airon Corporation — 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

K121379 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: Airon Corporation

Sources (1)

FDA UDI 63df0ae9-e318-4be6-8dfa-b27a15d3a22a 38 fields · synced May 30, 2026