Little Martin's Drawer

GUDID 00854878007070

Fetal Doppler_Blue

EBZNS HOLDINGS LLC

Foetal Doppler system
Primary Device ID00854878007070
NIH Device Record Key33409c8d-6d44-4531-af50-10248e331a02
Commercial Distribution StatusIn Commercial Distribution
Brand NameLittle Martin's Drawer
Version Model NumberBFD1609
Company DUNS080521145
Company NameEBZNS HOLDINGS LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854878007070 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-18