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AirLife™ M1097109

by AirLife Finland Oy

AirLife M1097109 is a blanket/pad infant phototherapy unit (FDA Class I; FDA product code KME, Bedding, Disposable, Medical) made by AirLife Finland Oy, listed in FDA GUDID since 17 Apr 2025 (UDI-DI 10889483603048), registry data as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889483603048 UDI-DI Date17 Apr 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  • Withdrawn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
AirLife™
Generic name
Blanket/pad infant phototherapy unit
Model / Ref / Catalog
M1097109
Primary DI / UDI-DI
10889483603048
FDA product code
KME
GMDN term
Blanket/pad infant phototherapy unit
Device class
Class I
Regulation number
880.6060
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blanket/pad infant phototherapy unit

Other devices from AirLife Finland Oy

See all devices from AirLife Finland Oy →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)