Zephyr BH3-M2

GUDID 90884521725467

BioModule

ZEPHYR TECHNOLOGY LLC

Electrocardiograph, professional, single-channel

• Primary Device ID: 90884521725467
• NIH Device Record Key: cb53e50d-55d5-488b-bb99-9b3798ec415f
• Commercial Distribution Discontinuation: 2018-03-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Zephyr
• Version Model Number: BH3-M2
• Catalog Number: BH3-M2
• Company DUNS: 796678527
• Company Name: ZEPHYR TECHNOLOGY LLC
• 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: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521725461 [Primary]
GS1	90884521725467 [Package]; Contains: 10884521725461; Package: CASE [999 Units]; Discontinued: 2018-03-26; Not in Commercial Distribution

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-03-10
• Device Publish Date: 2018-01-24

On-Brand Devices [Zephyr]

• 10884521758995: Zephyr 5-Bay BioModule Charger For use with BH3 BioModule
• 10884521758964: Single Bay BioModule Charger
• 90884521725467: BioModule