CLARAVUE

GUDID 13700506300171

CLARAVUE PM 5 RT US

NISSHA MEDICAL TECHNOLOGIES SAS

Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use

• Primary Device ID: 13700506300171
• NIH Device Record Key: 3f4047e4-e101-480b-92c5-207884dafe97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLARAVUE
• Version Model Number: 50604-US
• Company DUNS: 391906658
• Company Name: NISSHA MEDICAL TECHNOLOGIES SAS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700506300174 [Primary]
GS1	13700506300171 [Package]; Contains: 03700506300174; Package: Box [30 Units]; In Commercial Distribution
GS1	23700506300178 [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: 2023-04-13
• Device Publish Date: 2023-04-05

On-Brand Devices [CLARAVUE]

• 03700506300013: Set of 3 Pateint Monitoring ECG Pre Wired Electrodes Radio Translucent for Neonat/Pediatric Pati
• 03700506300136: Set of 10 Patient Monitoring ECG Pre Wired Electrodes Radio Translucent for Adult Patients
• 03700506319527: Set of 10 Patient Monitoring ECG Pre Wired Electrodes Radio Translucent for Adult Patients
• 13700506300171: CLARAVUE PM 5 RT US
• 13700506300157: CLARAVUE PM 6 RT US
• 03700506300099: CLARAVUE PM 4 RT US