Omron Body Composition Monitor and Scale with Bluetooth BCM-500

GUDID 10073796233508

Body composition monitor with scale and Bluetooth and smart tracking of 6 body metrics.

Omron Healthcare, Inc.

Bioelectrical body composition analyser

• Primary Device ID: 10073796233508
• NIH Device Record Key: d965f097-d54e-4c16-adb4-0f5ffcf0a185
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Body Composition Monitor and Scale with Bluetooth
• Version Model Number: BCM-500
• Catalog Number: BCM-500
• Company DUNS: 054318779
• Company Name: Omron Healthcare, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com
• Phone: 1-800-634-4350
• Email: quality@ohi.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796233501 [Primary]
GS1	10073796233508 [Package]; Contains: 00073796233501; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062043

FDA Product Code

• MNW: Analyzer, Body Composition
• PUH: Analyzer, Body Composition, Exempt

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: 2019-08-27
• Device Publish Date: 2019-08-19

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