Venni / Biolight

GUDID 00852503007204

Venni / Biolight Fetal Monitor

VENNI INSTRUMENTS INC.

Cardiotocograph Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor
Primary Device ID00852503007204
NIH Device Record Key522b75c4-b087-4a80-95b4-0458109a93fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenni / Biolight
Version Model NumberF80
Company DUNS960516735
Company NameVENNI INSTRUMENTS INC.
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS100852503007204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGMSystem, Monitoring, Perinatal

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 Date2016-10-06

On-Brand Devices [Venni / Biolight]

00852503007211Venni / Biolight Fetal Monitor
00852503007204Venni / Biolight Fetal Monitor
00852503007198Venni / Biolight 12-channel EKG machine
00852503007181Venni / Biolight 12-channel EKG machine
00852503007174Venni / Biolight 3-channel EKG machine
00852503007167Venni / Biolight 12.1" multi-parameter modular patient monitor
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