FDA UDI
In Commercial Distribution
🇺🇸 United States
Neeva Baby
DI: 00860005571925
·
Model: NB Fetal Doppler 2MHz Mini
·
Sebe Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Neeva Baby
- Primary DI
- 00860005571925
- Version / Model
- NB Fetal Doppler 2MHz Mini
- Company Name
- Sebe Inc
- Labeler DUNS
- 204186571
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-18
- Public Version
- 1
- Public Version Date
- 2020-10-26
- Public Version Status
- New
- Public Device Record Key
- 6bfa3cb0-d944-464f-a52e-ed84c1a8d6da
Device Description
The Neeva Baby Fetal Doppler Mini is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00860005571925 | GS1 |