| Primary Device ID | 07640135140702 |
| NIH Device Record Key | 8445fbb1-0adf-490c-9f99-434d26add19e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 2nd Gen CentriMag Primary Console |
| Version Model Number | 201-90411 |
| Catalog Number | 201-90411 |
| Company DUNS | 486066918 |
| Company Name | Thoratec Switzerland GmbH |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70.2 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640135140702 [Primary] |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-02-06 |
| Device Publish Date | 2014-09-20 |
| 07640135140276 - CentriMag™ | 2022-04-06 Pressure Cable for BD DTX Plus Transducer |
| 07640135140283 - CentriMag™ | 2022-04-06 Centrimag Motor Bracket (45 degree) |
| 07640135140412 - CentriMag™ | 2022-04-06 Pressure Cable for Bbraun Combitrans Pressure Transducers |
| 07640135140429 - CentriMag™ | 2022-04-06 Pressure Cable for Smiths Medical TranStar Pressure Sensors |
| 07640135140436 - CentriMag™ | 2022-04-06 Pressure Cable for Smiths Medical LogiCal Plus Pressure Sensors |
| 07640135140443 - CentriMag™ | 2022-04-06 Pressure cable for Biosensors' Accutrans and Utah Medical's Deltran II DPT-248 Pressure Sensors |
| 07640135140481 - CentriMag™ | 2022-04-06 Pressure Cable for Argon Medical CDX III Pressure Transducers |
| 07640135140566 - CentriMag™ | 2022-04-06 USB Stick containing Mag Log Converter Software |