| Primary Device ID | 10850390007243 |
| NIH Device Record Key | 57e55c32-d0e6-4815-9d76-b43de2aca601 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PrimusRS |
| Version Model Number | PrimusRS |
| Company DUNS | 021461470 |
| Company Name | BTE TECHNOLOGIES, INC. |
| 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 | 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 | 410-850-0333 |
| Customer_Service@btetechnologies.com | |
| Phone | 410-850-0333 |
| Customer_Service@btetechnologies.com |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10850390007243 [Primary] |
| ISD | Exerciser, Measuring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-05-13 |
| Device Publish Date | 2016-08-25 |
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