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AMSafe® Neutral High-Pressure Extension Set w/ Needle-Free Valve, Rotating Luer 1

by Amsino International, Inc.

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 Number10704411020608 UDI-DI Date7 Nov 2025ListedStatusListed 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  • Withdrawn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
AMSafe® Neutral High-Pressure Extension Set w/ Needle-Free Valve, Rotating Luer
Generic Name
Intravenous administration tubing extension set
Model / Ref / Catalog
1, AE0108-HP
Description
Length: 20 cm (8 in.) Priming Volume: 0.30 ml Power injection rated to 400 psi and 10 mL/sec
Primary DI / UDI-DI
10704411020608
510(k) Number
FDA Product Code
FPA
GMDN Term
Intravenous administration tubing extension set
Device Class
Class II
Regulation Number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K221481)

Other devices from Amsino International, Inc.

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Properties

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

Other properties (8)

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