FDA UDI
In Commercial Distribution
🇺🇸 United States
HeraBEAT
DI: 07290111520129
·
Model: HeraBEAT US
·
HERA MED LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HeraBEAT
- Primary DI
- 07290111520129
- Version / Model
- HeraBEAT US
- Catalog Number
- PACHBT000US
- Company Name
- HERA MED LTD
- Labeler DUNS
- 600058601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-20
- Public Version
- 1
- Public Version Date
- 2020-08-28
- Public Version Status
- New
- Public Device Record Key
- af509093-0aa8-4945-b4fb-b1a20cf6c09a
Device Description
HeraBEAT US is a hand-held, battery powered audio Doppler device integrated with 2MHz probe, used for detecting and displaying the fetal heart rate (FHR) and FHR sound. The device uses an optical sensor to distinguish between the FHR and the maternal heart rate (MHR) to eliminate “crosstalk” in the FHR display.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KNG | Monitor, Ultrasonic, Fetal | Obstetrics/Gynecology | 884.2660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34040 | Foetal Doppler system | A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290111520126 | GS1 | Carton | 12 | In Commercial Distribution | |
| Primary | 07290111520129 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191110 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal