pNeuton

FDA UDI

Class II (US FDA UDI)

by Airon Corporation

Identity

Trade Name: pNeuton FDA UDI
Generic Name: Portable pneumatic ventilator FDA UDI
Device Name: pNeuton Ventilator, mini neo FDA UDI
Model / Reference: mini neo FDA UDI
Description: pNeuton Ventilator, mini neo FDA UDI

Identifiers

Catalog Number: 20041 FDA UDI
Primary DI / UDI-DI: 00853678006719 FDA UDI
510(k) Number: K121379 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: Portable pneumatic ventilator 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Height — 6.0 Inch FDA UDI
Width — 8.7 Inch FDA UDI
Depth — 7.8 Inch FDA UDI
Weight — 9 Pound FDA UDI

Category: Portable pneumatic ventilator

pNeuton by Airon Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Portable pneumatic ventilator.

Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
Emergent Respiratory — MDL SOLUTIONS INCORPORATED · Class II
Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
Percussionaire — Percussionaire Corporation · Class II
PAHI VersalVent — Pan-America Hyperbarics, Inc. · Class II
CAREvent MRI — O-Two Medical Technologies Inc · Class II
Bio-Med Devices, Inc. — Bio-Med Devices, 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 061a1eb1-412f-45bd-94db-5bf35b56c8fd 38 fields · synced Jun 6, 2026