Draeger 5-Lead ECG - Reprocessed

GUDID 10816317023963

ECG Cable, 5-Lead, Single Patient Use, IEC2

RENU MEDICAL, INC

Electrocardiographic lead set, reprocessed

• Primary Device ID: 10816317023963
• NIH Device Record Key: ca2e5f64-bf19-4839-8ba4-eee0f96bebfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Draeger 5-Lead ECG - Reprocessed
• Version Model Number: RM-MP00881
• 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: true
• 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	00816317023966 [Primary]
GS1	10816317023963 [Package]; Contains: 00816317023966; 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: 2021-03-16
• Device Publish Date: 2021-03-08

Devices Manufactured by RENU MEDICAL, INC

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