← Back to catalogue

pNeuton

FDA UDI

Class II (US FDA UDI)

by Airon Corporation

Identity

Trade Name
pNeuton FDA UDI
Generic Name
Non-respiratory device ambient air filter FDA UDI
Device Name
Bacterial/Viral Filter, main line or expiratory FDA UDI
Model / Reference
58210 FDA UDI
Description
Bacterial/Viral Filter, main line or expiratory FDA UDI

Identifiers

Catalog Number
58210 FDA UDI
Primary DI / UDI-DI
00853678006672 FDA UDI
510(k) Number
K925217 FDA UDI
FDA Product Code
CAH FDA UDI
GMDN Term
Non-respiratory device ambient air filter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5260 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 0.04 Pound FDA UDI
Height — 2.50 Inch FDA UDI
Width — 2.50 Inch FDA UDI
Length — 2.75 Inch FDA UDI

Category: Non-respiratory device ambient air filter

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

Similar devices

Also classified as Non-respiratory device ambient air filter.

Cleared under the same submission

K925217 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Airon Corporation

Sources (1)

  • FDA UDI 18cfe39f-0822-4fec-8aea-a0c6f558513c 38 fields · synced May 31, 2026