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AERIS Airway - Male Luer Kit 101MM

by Airway Innovations, Inc.

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 Number00850077887031 UDI-DI Date8 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AERIS Airway - Male Luer Kit
Generic Name
Nasal oxygen cannula, carbon-dioxide-sampling
Model / Reference
101MM
Primary DI / UDI-DI
00850077887031
FDA Product Code
CAT, CAE
GMDN Term
Nasal oxygen cannula, carbon-dioxide-sampling
Device Class
Class I
Regulation Number
868.5340, 868.5110
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Other devices from Airway Innovations, Inc.

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No