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AMSafe SP 0.9% NaCl IVF1010PX

by MedXL

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00682686005403 UDI-DI Date29 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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 SP 0.9% NaCl
Generic Name
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Model / Ref / Catalog
IVF1010PX
Primary DI / UDI-DI
00682686005403
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
In Commercial Distribution
Size
Total Volume — 10 Milliliter

Related devices

Cleared under the same submission (K233623)

Other devices from MedXL

See all devices from MedXL →

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