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AMSure ® Foley Catheters Tray 1

by Amsino International, Inc. 3 variants

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 Number10704411014867 UDI-DI Date4 Apr 2022ListedStatusListed 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  • Withdrawn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 ® Foley Catheters Tray
Generic Name
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Model / Ref / Catalog
1, AS89316H
Description
2000 mL Drainage Bag Hydrophilic Latex Foley Catheter 5 cc Balloon 16Fr.
Primary DI / UDI-DI
10704411014867
FDA Product Code
FCM
GMDN Term
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Device Class
Class II
Regulation Number
876.5130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use

Other devices from Amsino International, Inc.

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Properties

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

Other properties (8)

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