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MonitAir 1.3.x

by Monitair LLC

MonitAir 1.3.x is a Class I device made by Monitair LLC, listed in FDA GUDID since 13 May 2025 (UDI-DI 00860012679270), registry data as of 8 Nov 2026.

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

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860012679270 UDI-DI Date13 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
MonitAir
Generic name
Vulnerable patient home-monitoring software, professional-only
Model / reference
1.3.x
Primary DI / UDI-DI
00860012679270
FDA product code
OUG
GMDN term
Vulnerable patient home-monitoring software, professional-only
Device class
Class I
Regulation number
880.6310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vulnerable patient home-monitoring software, professional-only

Similar devices

Other devices filed under FDA product code OUG (Medical Device Data System).

Other devices from Monitair LLC

See all devices from Monitair LLC →

Properties

  • Premarket exempt
Other properties (14, all answered No)