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AMSure ® Hydrophilic Latex Foley Catheters 1

by Amsino International, Inc. 13 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number10704411017080 UDI-DI Date15 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AMSure ® Hydrophilic Latex Foley Catheters
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Model / Ref / Catalog
1, AS41012HC
Description
Two-Way 12FR 5cc 16” Coude tip
Primary DI / UDI-DI
10704411017080
510(k) Number
FDA Product Code
EZL
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device Class
Class II
Regulation Number
876.5130
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K091699)

Show all (12)

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