| Primary Device ID | 07640135140429 |
| NIH Device Record Key | 69a3bd97-4495-4619-b92f-6289bc690a9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CentriMag™ |
| Version Model Number | 201-50129 |
| Catalog Number | 201-50129 |
| Company DUNS | 486066918 |
| Company Name | Thoratec Switzerland GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | false |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 79.3 KiloPascal and 101.3 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640135140429 [Primary] |
| KRI | ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-06 |
| Device Publish Date | 2022-03-29 |
| 07640135140566 | USB Stick containing Mag Log Converter Software |
| 07640135140481 | Pressure Cable for Argon Medical CDX III Pressure Transducers |
| 07640135140443 | Pressure cable for Biosensors' Accutrans and Utah Medical's Deltran II DPT-248 Pressure Sensors |
| 07640135140436 | Pressure Cable for Smiths Medical LogiCal Plus Pressure Sensors |
| 07640135140429 | Pressure Cable for Smiths Medical TranStar Pressure Sensors |
| 07640135140412 | Pressure Cable for Bbraun Combitrans Pressure Transducers |
| 07640135140283 | Centrimag Motor Bracket (45 degree) |
| 07640135140276 | Pressure Cable for BD DTX Plus Transducer |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CENTRIMAG 87581813 5915360 Live/Registered |
Thoratec, LLC 2017-08-24 |
![]() CENTRIMAG 87212973 5231717 Live/Registered |
Thoratec LLC 2016-10-24 |
![]() CENTRIMAG 76257306 2599358 Live/Registered |
THORATEC LLC 2001-05-15 |