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pNeuton Model A Start-up Kit with 8ft Patient Circuit

by Airon Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00853678006726 UDI-DI Date18 Dec 2025ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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, 20060
Primary DI / UDI-DI
00853678006726
GMDN Term
Portable pneumatic ventilator
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Depth — 7.3 Inch
Width — 10.0 Inch
Height — 5.0 Inch
Weight — 6.5 Pound

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Properties

  • Prescription Use
  • Convenience Kit
  • Serial Number

Other properties (11)

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