Venni / Biolight

GUDID 00852503007174

Venni / Biolight 3-channel EKG machine

VENNI INSTRUMENTS INC.

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