| Primary Device ID | 07640135140320 |
| NIH Device Record Key | 91ee0347-5130-44ff-90bf-e9905d4102a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONSOLE STANDOFF |
| Version Model Number | 104305 |
| Catalog Number | 104305 |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640135140320 [Primary] |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-31 |
| Device Publish Date | 2014-09-20 |
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