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Spirometrics D1020

by Spirometrics, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00855784004283 UDI-DI Date3 Apr 2017ListedStatusListed GUDID: not 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  • Withdrawn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
Spirometrics
Generic Name
Breathing mouthpiece, single-use
Model / Reference
D1020
Primary DI / UDI-DI
00855784004283
FDA Product Code
BYP
GMDN Term
Breathing mouthpiece, single-use
Device Class
Class I
Regulation Number
868.5620
GUDID distribution status
Not in Commercial Distribution

Other devices from Spirometrics, Inc.

See all devices from Spirometrics, Inc. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No