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Soft-Cuf 2321

by GE Medical Systems Information Technologies, Inc.

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 Number00840682106764 UDI-DI Date30 Jun 2016ListedStatusListed 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  • Withdrawn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
Soft-Cuf
Generic Name
Blood pressure cuff, reusable
Model / Reference
2321
Primary DI / UDI-DI
00840682106764
510(k) Number
FDA Product Code
DXQ
GMDN Term
Blood pressure cuff, reusable
Device Class
Class II
Regulation Number
870.1120
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K120125)

Show all (11)

Other devices from GE Medical Systems Information Technologies, Inc.

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Properties

  • Contains Latex
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No