Advantage Medical Cable ECG Lead

GUDID 10816317023819

AMC - Disp. 5 Lead DIN to Pinch Leadset

RENU MEDICAL, INC

Electrocardiographic lead set, reprocessed

• Primary Device ID: 10816317023819
• NIH Device Record Key: dfbc0ca3-7edf-4125-9424-0a88e8204255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage Medical Cable ECG Lead
• Version Model Number: RM-LW-329DS50/5A
• Company DUNS: 100439103
• Company Name: RENU MEDICAL, INC
• Device Count: 1
• DM Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816317023812 [Primary]
GS1	10816317023819 [Package]; Contains: 00816317023812; 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: 2021-03-04
• Device Publish Date: 2021-02-24

On-Brand Devices [Advantage Medical Cable ECG Lead]

• 10816317023833: AMC&E - Disp. Pinch 3 Leadset
• 10816317023826: AMC - Disp. 5 Lead DIN to Pinch Telemetry Leadset
• 10816317023819: AMC - Disp. 5 Lead DIN to Pinch Leadset