My Baby's Heartbeat Bear Fetal Doppler

GUDID 16970442090314

Vcomin Technlogy Limited

Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system
Primary Device ID16970442090314
NIH Device Record Keye04f7a5d-d4cd-4b21-ab83-78ab73ab51cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMy Baby's Heartbeat Bear Fetal Doppler
Version Model NumberFD-590B
Company DUNS548312355
Company NameVcomin Technlogy Limited
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106970442090317 [Primary]
GS116970442090314 [Package]
Contains: 06970442090317
Package: box [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNGMonitor, Ultrasonic, Fetal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-03
Device Publish Date2020-11-25