Claravue 32028778 50601-US

GUDID 13700506300119

Set of 5 Pre Wired RT Adult Electrodes

GRAPHIC CONTROLS ACQUISITION CORP

Electrocardiographic electrode, single-use

• Primary Device ID: 13700506300119
• NIH Device Record Key: a7df2607-c58c-4382-ab8d-850c174d1e69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Claravue
• Version Model Number: CLARAVUE PM M5 RT US
• Catalog Number: 32028778 50601-US
• Company DUNS: 002111896
• Company Name: GRAPHIC CONTROLS ACQUISITION CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com
• Phone: +33139726666
• Email: FRorders@nisshamedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700506300112 [Primary]
GS1	13700506300119 [Package]; Contains: 03700506300112; Package: Box [30 Units]; In Commercial Distribution
GS1	23700506300116 [Package]; Package: Case [360 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101685

FDA Product Code

• DRX: Electrode, Electrocardiograph

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: 2021-07-21
• Device Publish Date: 2021-07-13

Devices Manufactured by GRAPHIC CONTROLS ACQUISITION CORP

• 03700506307067 - Bard: 2025-12-15 CUSTOM CABLE-BARD/QUICK CONNECT
• 03700506307081 - Biosense: 2025-12-15 CUSTOM ADAPTER-BARD/CARTO3 10 LD
• 03700506307098 - Physio Control: 2025-12-15 CUSTOM ADAPTER-BARD/PHYSIO 10 LD
• 03700506307104 - St Jude Medical: 2025-12-15 CUSTOM ADAPTER-BARD/ST.JUDE 10 LD
• 00009336010332 - SilverRest Resting ECG TAB Electrode: 2024-11-22 SilverRest Resting ECG TAB Electrode
• 00009336002559 - Vermed: 2024-06-06 3-Lead,Safety Din to Mini Pinch,29" Leadwire Set
• 00009336002573 - Vermed: 2024-06-06 3 Lead DIN to Pinch, 29", AHA
• 00009336002597 - Vermed: 2024-06-06 LWG-3090029/5A 5 Lead DIN to Pinch, 29IN AHA