FDA UDI
In Commercial Distribution
🇺🇸 United States
B-Right Screen Fetal Heart
DI: 03760415600048
·
Model: V1.1.x
·
BRIGHTHEART
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- B-Right Screen Fetal Heart
- Primary DI
- 03760415600048
- Version / Model
- V1.1.x
- Company Name
- BRIGHTHEART
- Labeler DUNS
- 279036039
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-13
- Public Version
- 1
- Public Version Date
- 2025-10-21
- Public Version Status
- New
- Public Device Record Key
- 19a1826c-e203-4b02-9498-2fa18585c8c6
Device Description
Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | Radiology | 892.2060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40873 | Ultrasound imaging system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
| 44783 | Cardiac mapping system application software | An individual software program or group of programs, routines and/or algorithms that add specific image processing and/or analysis capabilities to a cardiac mapping system computer for storing, processing and management of electronic information/data used to interpret cardiac physiology parameters. It is a basic set of application programs and routines used for cardiac mapping computer-controlled imaging which can be upgraded to correct programming errors or to add new system capabilities. An application program package is typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760415600048 | GS1 | ||||
| Previous | 03760415600000 | GS1 |