LifeSignals

GUDID B353LP12502

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch

LIFESIGNALS, INC.

Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder

• Primary Device ID: B353LP12502
• NIH Device Record Key: 710fb91c-8850-4a2e-b412-d8d192e63152
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeSignals
• Version Model Number: LP1250
• Company DUNS: 798830720
• Company Name: LIFESIGNALS, INC.
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com
• Phone: 510.770.6412
• Email: saravanan@lifesignals.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B353LP12501 [Primary]
HIBCC	B353LP12502 [Package]; Contains: B353LP12501; Package: Small BOx [25 Units]; In Commercial Distribution
HIBCC	B353LP12503 [Package]; Package: Big Box [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200690

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

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: 2020-08-19
• Device Publish Date: 2020-08-11

On-Brand Devices [LifeSignals]

• B353LP12502: Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
• B353LP12532: Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
• B353LP12511: Wearable Biosensor - ECG Remote Monitoring Biosensor