| Primary Device ID | 07640135140597 |
| NIH Device Record Key | e0cb6668-3387-46bf-a6ae-bf78af99c0a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MONITOR ARM CLAMP |
| Version Model Number | 201-52171 |
| Catalog Number | 201-52171 |
| 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 | 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 | 07640135140597 [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 |
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