FDA.reportPublic FDA data

Venni / Biolight

Primary DI
00852503007204
Brand
Venni / Biolight
Company
VENNI INSTRUMENTS INC.
Model
F80
Device description
Venni / Biolight Fetal Monitor
Published
2016-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131941000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131941000FETAL MONITORSGuangdong Biolight Meditech Co., Ltd.2014-05-15HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852503007204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852503007204008525030072048525030072040852503007204

GMDN Terms#

Term, Definition table
TermDefinition
CardiotocographA mains electricity (AC-powered) patient monitor that displays the relationship between maternal labour and the foetal heart rate by means of combining and coordinating uterine contraction and foetal heart monitoring during the perinatal period. The uterine contractions are usually recorded using a tocodynamometer (a pressure transducer) which is strapped onto the mother's abdomen. Commonly known as a tococardiograph or a cardiotocograph (CTG) machine, the heart rate is typically measured with a dedicated ultrasound transducer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
960516735
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852503007211Venni / Biolight F902016-10-06
00852503007006VenniVI-8080P2016-09-27
00852503007013VenniVI-1060P2016-09-27
00852503007020VenniVI-1220P2016-09-27
00852503007037VenniVI-1510P2016-09-27
00852503007044VenniVI-1200MT2016-09-27
00852503007051VenniVI-1500MT2016-09-27
00852503007068VenniVI-7080P2016-09-28
00852503007075VenniVI-300A2016-09-27
00852503007082BiolightM85002016-10-06
00852503007099BiolightM8000A2016-10-06
00852503007105BiolightM9000A2016-10-06
00852503007112BiolightM95002016-10-06
00852503007129BiolightQ52016-10-06
00852503007136BiolightQ72016-10-06
00852503007143Biolight M70002016-10-06
00852503007150Biolight V62016-10-06
00852503007167Venni / Biolight A52016-10-06
00852503007174Venni / Biolight E302016-10-06
00852503007181Venni / BiolightE702016-10-06

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Primary DI, Brand, Company table
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