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AMSure® 0.9% Sodium Chloride lrrigation USP 500 mL, Sterile 1

by Amsino International, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

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 Number00704411020502 UDI-DI Date5 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0511-2024 FDA Class I initiated 6 Nov 2023 on shared 510(k) K083042
    • Ongoing Z-0513-2024 FDA Class I initiated 6 Nov 2023

    Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AMSure® 0.9% Sodium Chloride lrrigation USP 500 mL, Sterile
Generic Name
Non-antimicrobial wound irrigation solution, saline
Model / Ref / Catalog
1, AS-6380
Primary DI / UDI-DI
00704411020502
510(k) Number
FDA Product Code
FRO
GMDN Term
Non-antimicrobial wound irrigation solution, saline
Device Class
U
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K083042)

Show all (12)

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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