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AMSafe ® Pre-Filled Normal Saline Flush Syringe 1

by Amsino International, Inc. 8 variants

Listed FDA GUDID listing, not in commercial distribution

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 Number30704411016643 UDI-DI Date31 Aug 2023ListedStatusListed GUDID: not 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  • Withdrawn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
AMSafe ® Pre-Filled Normal Saline Flush Syringe
Generic Name
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Model / Ref / Catalog
1, IVF1010SS-WB
Primary DI / UDI-DI
30704411016643
510(k) Number
FDA Product Code
NGT
GMDN Term
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Device Class
Class II
Regulation Number
880.5200
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K183473)

Other devices from Amsino International, Inc.

See all devices from Amsino International, Inc. →

Properties

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

Other properties (10)

  • Sterile: No
  • 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