Advantage Medical Cable ECG Leads

GUDID 10816317023369

AMC – Disp. 5 Lead Disposable Philips MX-40 Compatible Leadset

RENU MEDICAL, INC

Electrocardiographic lead set, reprocessed

• Primary Device ID: 10816317023369
• NIH Device Record Key: ff9978dd-f517-4922-a015-5752e9771b4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage Medical Cable ECG Leads
• Version Model Number: RM-LW-314DS50/5A
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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	00816317023362 [Primary]
GS1	10816317023369 [Package]; Contains: 00816317023362; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-08-02
• Device Publish Date: 2017-06-30

On-Brand Devices [Advantage Medical Cable ECG Leads]

• 10861317023376: AMC - Disp. 6 Lead Grouped Set, Pinch to Molded Nihon Kohden
• 10861317023369: AMC – Disp. 5 Lead Disposable Philips MX-40 Compatible Leadset
• 10861317023222: AMC - Disp. 3 Lead DIN to Snap Leadset
• 10861317020689: AMC - Disp. 5 Lead Grouped Set Pinch to Telepack
• 10861317020672: AMC - Disp. 5 Lead DIN to Pinch Telemetry
• 10861317020665: AMC - Disp. 5 Lead DIN to Pinch Leadset
• 10861317020658: AMC- Disp. Pinch 3 Lead
• 10816317023376: AMC - Disp. 6 Lead Grouped Set, Pinch to Molded Nihon Kohden
• 10816317023369: AMC – Disp. 5 Lead Disposable Philips MX-40 Compatible Leadset
• 10816317023222: AMC - Disp. 3 Lead DIN to Snap Leadset
• 10816317020689: AMC - Disp. 5 Lead Grouped Set Pinch to Telepack
• 10816317020672: AMC - Disp. 5 Lead DIN to Pinch Telemetry
• 10816317020665: AMC - Disp. 5 Lead DIN to Pinch Leadset
• 10816317020658: AMC- Disp. Pinch 3 Lead
• 10816317024052: RM-LWM-309DS120/5AT
• 10816317024090: AMC - Disp. 5 Lead Grouped Set Pinch (Grabber)
• 10816317024083: AMC - Disp. 6 Lead Grouped Set
• 10816317024076: AMC - Disp. 3 Lead DIN to Pinch Leadset
• 10816317024069: AMC - Disp. 5 Lead DIN to Pinch Leadset
• 10816317024144: AMC - 5 Lead Disposable DIN to Pinch, Shld, 120", OM Combiner, AHA, SS