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pNeuton Model A with 6ft Patient Circuit

by Airon Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00853678006733 UDI-DI Date19 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Portable pneumatic ventilator
Model / Ref / Catalog
A, 20059
Primary DI / UDI-DI
00853678006733
510(k) Number
FDA Product Code
CBK
GMDN Term
Portable pneumatic ventilator
Device Class
Class II
Regulation Number
868.5895
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Weight — 6.5 Pound
Depth — 7.3 Inch
Height — 5.0 Inch
Width — 10.0 Inch

Related devices

Cleared under the same submission (K043085)

Other devices from Airon Corporation

See all devices from Airon Corporation →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No