| Primary Device ID | 04987671041517 |
| NIH Device Record Key | d7ba96c7-1c7b-4e9b-8d9e-68c85b64be93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEMODIALYSIS DELIVERY SYSTEM |
| Version Model Number | DBB-06 |
| Company DUNS | 690542378 |
| Company Name | NIKKISO CO.,LTD. |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage. |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |