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Amplion Care Assurance F-SHS-3356-1

by Amplion Clinical Communications, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00850016398543 UDI-DI Date30 Apr 2020ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Amplion Care Assurance
Generic Name
Nurse call system
Model / Ref / Catalog
F-SHS-3356-1
Primary DI / UDI-DI
00850016398543
FDA Product Code
IQA
GMDN Term
Nurse call system
Device Class
Class II
Regulation Number
890.3725
GUDID distribution status
Not in Commercial Distribution

Properties

  • Premarket Exempt
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No