Digital Electrocardigraph

GUDID 06932562310157

Guangdong Biolight Meditech Co., Ltd.

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• Primary Device ID: 06932562310157
• NIH Device Record Key: 3581432e-5a75-4950-a8a6-21a2231258b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Electrocardigraph
• Version Model Number: E30
• Company DUNS: 530120146
• Company Name: Guangdong Biolight Meditech Co., Ltd.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06932562310157 [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: 2016-10-20

On-Brand Devices [Digital Electrocardigraph]

• 06932562310157: E30
• 06932562310072: E70