Skip to content

B-Right Screen Fetal Heart V1.1.x

by Brightheart

Listed FDA GUDID listing, no authorization on record

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 Number03760415600048 UDI-DI Date13 Oct 2025ListedStatusListed GUDID: 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  • Withdrawn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
B-Right Screen Fetal Heart
Generic Name
Ultrasound imaging system application software
Model / Reference
V1.1.x
Primary DI / UDI-DI
03760415600048
FDA Product Code
POK
GMDN Term
Ultrasound imaging system application software
Device Class
Class II
Regulation Number
892.2060
GUDID distribution status
In Commercial Distribution

Other devices from Brightheart

See all devices from Brightheart →

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