FDA.reportPublic FDA data

Biolight

Primary DI
00852503007136
Brand
Biolight
Company
VENNI INSTRUMENTS INC.
Model
Q7
Device description
"Biolight 15.1"" multi-parameter modular patient monitor"
Published
2016-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852503007136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852503007136008525030071368525030071360852503007136

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-822-5887service@biolightmeditechusa.com

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
00852503007204Venni / BiolightF802016-10-06
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
00852503007143Biolight M70002016-10-06
00852503007150Biolight V62016-10-06
00852503007167Venni / Biolight A52016-10-06
00852503007174Venni / Biolight E302016-10-06
00852503007181Venni / BiolightE702016-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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08719689142179QMAPP Fysicon B.V.MWI2026-05-19
10197344213245MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08