FDA.reportPublic FDA data

Venni / Biolight

Primary DI
00852503007174
Brand
Venni / Biolight
Company
VENNI INSTRUMENTS INC.
Model
E30
Device description
Venni / Biolight 3-channel EKG machine
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
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131858000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131858000DIGITAL ELECTROCARDIOGRAPHGuangdong Biolight Meditech Co., Ltd.2014-06-11DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852503007174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852503007174008525030071748525030071740852503007174

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included.

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
00852503007136BiolightQ72016-10-06
00852503007143Biolight M70002016-10-06
00852503007150Biolight V62016-10-06
00852503007167Venni / Biolight A52016-10-06
00852503007181Venni / BiolightE702016-10-06

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Primary DI, Brand, Company table
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