Venni / Biolight

GUDID 00852503007174

Venni / Biolight 3-channel EKG machine

VENNI INSTRUMENTS INC.

Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel

• Primary Device ID: 00852503007174
• NIH Device Record Key: 98a84c8a-1610-422f-9414-12f9f9f19663
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venni / Biolight
• Version Model Number: E30
• Company DUNS: 960516735
• Company Name: VENNI INSTRUMENTS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-822-5887
• Email: service@biolightmeditechusa.com
• Phone: 888-822-5887
• Email: service@biolightmeditechusa.com
• Phone: 888-822-5887
• Email: service@biolightmeditechusa.com
• Phone: 888-822-5887
• Email: service@biolightmeditechusa.com
• Phone: 888-822-5887
• Email: service@biolightmeditechusa.com
• Phone: 888-822-5887
• Email: service@biolightmeditechusa.com
• Phone: 888-822-5887
• Email: service@biolightmeditechusa.com
• Phone: 888-822-5887
• Email: service@biolightmeditechusa.com
• Phone: 888-822-5887
• Email: service@biolightmeditechusa.com
• Phone: 888-822-5887
• Email: service@biolightmeditechusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852503007174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131858

FDA Product Code

• DPS: Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-06

On-Brand Devices [Venni / Biolight ]

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