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AMSure® Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL 1

by Amsino International, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number40704411010334 UDI-DI Date12 May 2019ListedStatusListed 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  • Withdrawn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
AMSure® Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL
Generic Name
Inhalation therapy sterile water
Model / Ref / Catalog
1, AS0552
Primary DI / UDI-DI
40704411010334
FDA Product Code
BTT
GMDN Term
Inhalation therapy sterile water
Device Class
Class II
Regulation Number
868.5450
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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