Venni / Biolight

GUDID 00852503007211

Venni / Biolight Fetal Monitor

VENNI INSTRUMENTS INC.

Cardiotocograph
Primary Device ID00852503007211
NIH Device Record Key7ed71129-d3b3-49a9-a8d3-22c8b2d66ed6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenni / Biolight
Version Model NumberF90
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852503007211 [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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