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Lung Diffusion 1

by Middlesex Gases & Technologies, Inc.

Lung Diffusion 1 is a Class I device made by Middlesex Gases & Technologies, Inc., listed in FDA GUDID since 15 Dec 2022 (UDI-DI 00860009591721), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860009591721 UDI-DI Date15 Dec 2022ListedStatusListed 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  • Withdrawn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
Lung Diffusion
Generic name
Carbon monoxide breath analyser
Model / reference
1
Primary DI / UDI-DI
00860009591721
FDA product code
BXK
GMDN term
Carbon monoxide breath analyser
Device class
Class I
Regulation number
868.6400
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code BXK (Gas, Calibration (Specified Concentration)).

Other devices from Middlesex Gases & Technologies, Inc.

Properties

  • Single use
  • Prescription use
  • Premarket exempt
Other properties (12, all answered No)