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
KNG Monitor, Ultrasonic, Fetal

GMDN Terms

Code Name
34040 Foetal Doppler system

Identifiers

Type ID
Primary 00860005571925