INVOS PMAC71DOC

GUDID 10884521780170

Docking Station

Covidien LP

Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger

• Primary Device ID: 10884521780170
• NIH Device Record Key: 43d92c7b-6b5e-40ed-b0b6-43659ecce79e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INVOS
• Version Model Number: PMAC71DOC
• Catalog Number: PMAC71DOC
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: false
• Lot Batch: false
• Serial Number: true
• 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
• 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
• 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

Device Dimensions

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Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 61.6 KiloPascal and 107.5 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 61.6 KiloPascal and 107.5 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 61.6 KiloPascal and 107.5 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 61.6 KiloPascal and 107.5 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 61.6 KiloPascal and 107.5 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 61.6 KiloPascal and 107.5 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 61.6 KiloPascal and 107.5 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 61.6 KiloPascal and 107.5 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Handling Environment Atmospheric Pressure: Between 0.616 KiloPascal and 1.075 KiloPascal
• Storage Environment Atmospheric Pressure: Between 47 KiloPascal and 108 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 46 KiloPascal and 108 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521780170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182868

FDA Product Code

• MUD: Oximeter, tissue saturation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-07-31

On-Brand Devices [INVOS]

• 20884521211152: Adult SomaSensor Adult Disposable Regional Oxygen Saturation Sensor
• 20884521211138: OxyAlert NIRSensor Infant - Somatic
• 20884521211121: OxyAlert NIRSensor Infant - Cerebral
• 10884521106222: OxyAlert NIRSensor Cerebral/Somatic - Neonatal
• 10884521106086: OxyAlert NIRSensor Somatic - Neonatal
• 10884521552623: OxyAlert NIRSensor Cerebral - Neonatal
• 10884521105942: Pediatric SomaSensor
• 10884521105911: Pediatric SomaSensor
• 10884521105904: Adult SomaSensor Adult Disposable Regional Oxygen Saturation Sensor
• 10884521104228: Adult SomaSensor Adult Disposable Regional Oxygen Saturation Sensor > 40 kg only
• 10884521211193: CEREBRAL/SOMATIC OXIMETER
• 10884521211179: CEREBRAL/SOMATIC OXIMETER
• 30884521211166: Pediatric SomaSensor Pediatric Disposable Regional Oxygen Saturation Sensor
• 10884521780101: Preamplifier. For use with PM7100
• 10884521780071: PM7100 Patient Monitor
• 10884521712805: Preamplifier. For use with PM7100
• 10884521145597: Reusable Sensor Cable
• 40884521780119: Adult rSO2 Sensor
• 20884521556970: Adult rSO2 Sensor
• 10884521211117: OxyAlert NIRSensor Infant/Neonatal Sensor
• 10884521780170: Docking Station
• 10884521552609: 7100 Patient Monitor
• 10884521810112: Preamplifier;For use with PM7100
• 20884521810102: PM7100 Patient Monitor
• 10884521809789: Pediatric rSO2 Sensor
• 20884521810362: Infant Regional Saturation Sensor Infant/Neonatal
• 20884521810379: Infant Regional Saturation Sensor Cerebral/Somatic - Neonatal
• 10884521806436: Reusable Infant Sensor Adapter Cable for PM7100
• 10884521185913: Demo Sale, 5100C, Oximeter; Cerebral/Somatic Oximeter
• 10884521145627: Reusable Sensor Cable
• 10884521185906: Demo Sale, 5100C, Preamp CH 3 & 4
• 10884521185890: Demo Sale, 5100C, Preamp CH 1 & 2
• 10884521185876: Demo Loaner, 5100C, Preamp CH 3 & 4
• 10884521185869: Demo Loaner, 5100C, Preamp CH 1 & 2
• 10884521145580: Preamplifier B, Channel 3 and 4
• 10884521145573: Preamplifier A, Channel 1 and 2
• 10884521780163: Reusable Sensor Cable for 5100C, Channel 4
• 10884521780156: Reusable Sensor Cable for 5100C, Channel 3
• 10884521780149: Reusable Sensor Cable for 5100C, Channel 2
• 10884521780132: Reusable Sensor Cable for 5100C, Channel 1
• 10884521780125: Reusable Sensor Cable for PM7100
• 10884521211186: CEREBRAL/SOMATIC OXIMETER
• 10884521185883: Demo Loaner, 5100C, Oximeter
• 10884521528062: Adult Adjustable Field Test Device
• 10884521528055: Pediatric-Infant Adjustable Field Test Device
• 10884521145610: Reusable Sensor Cable
• 10884521145603: Reusable Sensor Cable
• 10884521832107: Demo Loaner, Preamplifier. For use with PM7100
• 10884521824416: Preamplifier B, Channel 3 and 4
• 10884521824409: Preamplifier A, Channel 1 and 2