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Fenom Flo™ 148029-502

by Medical Graphics Corp.

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 Number00810016252290 UDI-DI Date10 Jun 2026ListedStatusListed 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  • Withdrawn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

Trade Name
Fenom Flo™
Generic Name
Nitrogen monoxide analyser
Model / Reference
148029-502
Description
SW Fenom Flo V3.0.2 Download POC App
Primary DI / UDI-DI
00810016252290
510(k) Number
FDA Product Code
MXA
GMDN Term
Nitrogen monoxide analyser
Device Class
Class II
Regulation Number
862.3080
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251674)

Other devices from Medical Graphics Corp.

See all devices from Medical Graphics Corp. →

Properties

  • Prescription Use

Other properties (13)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No