INVOS SAFB-SM/USA

GUDID 20884521211152

Adult SomaSensor Adult Disposable Regional Oxygen Saturation Sensor

Covidien LP

Cerebral oximeter sensor, single-use

• Primary Device ID: 20884521211152
• NIH Device Record Key: bf470576-c865-401c-acb6-ab7164d6baad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INVOS
• Version Model Number: SAFB-SM/USA
• Catalog Number: SAFB-SM/USA
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521552685 [Package]; Contains: 30884521211159; Package: CASE [1120 Units]; In Commercial Distribution
GS1	20884521211152 [Package]; Contains: 30884521211159; Package: PACK_OR_INNER_PACK [20 Units]; In Commercial Distribution
GS1	30884521211159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082327

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: 2019-12-11
• 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