INVOS

GUDID 10884521185890

Demo Sale, 5100C, Preamp CH 1 & 2

Covidien LP

Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter Cerebral oximeter

• Primary Device ID: 10884521185890
• NIH Device Record Key: 77d038b5-dfd0-4818-9764-0dee1c70bf1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INVOS
• Version Model Number: DS5100C-PA
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *This Side Up;Keep Dry;Fragile
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521185890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091224

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: 5
• Public Version Date: 2022-05-03
• Device Publish Date: 2016-09-24

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