ECG Lead

GUDID 10816317023772

AMC - Disp. 5 Lead Grouped Set Pinch (Grabber)

RENU MEDICAL, INC

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• Primary Device ID: 10816317023772
• NIH Device Record Key: ddbfae00-ad98-4e85-980d-500f9ad17d7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG Lead
• Version Model Number: RM-LW-341DS50/5A
• Company DUNS: 100439103
• Company Name: RENU MEDICAL, INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816317023775 [Primary]
GS1	10816317023772 [Package]; Contains: 00816317023775; Package: case [25 Units]; In Commercial Distribution

FDA Product Code

• IKD: Cable, Electrode

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-07
• Device Publish Date: 2020-01-30

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