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Insufflator Filter Assembly 21001

by Armm Inc.

Insufflator Filter Assembly 21001 is a Class II device made by Armm Inc., listed in FDA GUDID since 8 Jun 2023 (UDI-DI 10850082007834), 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 Number10850082007834 UDI-DI Date8 Jun 2023ListedStatusListed 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  • Withdrawn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
Insufflator Filter Assembly
Generic name
Endoscopic insufflation tubing set, single-use
Model / reference
21001
Primary DI / UDI-DI
10850082007834
FDA product code
HIF
GMDN term
Endoscopic insufflation tubing set, single-use
Device class
Class II
Regulation number
884.1730
GUDID distribution status
In Commercial Distribution

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)