INVOS

GUDID 10884521552609

7100 Patient Monitor

Covidien LP

Cerebral oximeter

• Primary Device ID: 10884521552609
• NIH Device Record Key: 36dcf0db-abca-478c-bce0-29bdcff432be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INVOS
• Version Model Number: PM7100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521552609 [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: 2021-06-03
• Device Publish Date: 2019-01-17

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