LEADER 5915004

GUDID 50096295143855

LDR Talking Blood Pressure Monitor with Wide Range Arm Cuff 1 monitor Kit

Cardinal Health 110, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 50096295143855
• NIH Device Record Key: e3ee4062-5bea-4b0a-bff1-9f665408680b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEADER
• Version Model Number: 5915004
• Catalog Number: 5915004
• Company DUNS: 063997360
• Company Name: Cardinal Health 110, Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00096295143850 [Primary]
GS1	50096295143855 [Package]; Contains: 00096295143850; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202757

FDA Product Code

• DXN: System, measurement, blood-pressure, non-invasive

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: 2024-10-10
• Device Publish Date: 2024-10-02

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