INVOS
GUDID 10884521780132
Reusable Sensor Cable for 5100C, Channel 1
Covidien LP
Electrical-only medical device connection cable, reusable| Primary Device ID | 10884521780132 |
| NIH Device Record Key | ce2c91d3-6795-4130-88a8-f819aa9ea7b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INVOS |
| Version Model Number | PMAC71RSC-L-CH1 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 47 KiloPascal and 108 KiloPascal |
| Handling Environment Temperature | Between 16 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521780132 [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 | 2022-05-18 |
| 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 |
Trademark Results [INVOS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INVOS 73587935 1441862 Live/Registered |
SOMANETICS CORPORATION 1986-03-14 |
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