Philips ECG Lead

GUDID 10816317024120

Philips - AAMI 5 Lead Set M1668A, M1663A and M1949A

RENU MEDICAL, INC

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• Primary Device ID: 10816317024120
• NIH Device Record Key: cf2122a6-c6c8-49b7-a3fc-9678f06932c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips ECG Lead
• Version Model Number: RM-989803173131
• 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: false
• 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	00816317024123 [Primary]
GS1	10816317024120 [Package]; Contains: 00816317024123; Package: Case [20 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: 2023-09-21
• Device Publish Date: 2023-09-13

On-Brand Devices [Philips ECG Lead]

• 10816317024120: Philips - AAMI 5 Lead Set M1668A, M1663A and M1949A
• 10816317024137: Philips - 5 Lead Set, Disposable, Chest, AAMI