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ACIST HDi® Cart 017991

by ACIST Medical Systems, 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 Number10841716101202 UDI-DI Date9 Sep 2016ListedStatusListed 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  • Withdrawn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
ACIST HDi® Cart
Generic Name
Cardiovascular ultrasound imaging system
Model / Reference
017991
Primary DI / UDI-DI
10841716101202
FDA Product Code
OBJ
GMDN Term
Cardiovascular ultrasound imaging system
Device Class
Class II
Regulation Number
870.1200
GUDID distribution status
Not in Commercial Distribution

From the manufacturer

Manufacturer's product page: ACIST HDi®

Other devices from ACIST Medical Systems, Inc.

See all devices from ACIST Medical Systems, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: 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
  • Expiration Date: No