| Primary Device ID | 04580262010352 |
| NIH Device Record Key | 2be0b26e-93b7-4fce-a254-48b4880a0c0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dialysis Calibrator |
| Version Model Number | 20-27-0483F |
| Catalog Number | 20-27-0483F |
| Company DUNS | 696265656 |
| Company Name | TOKYO BOEKI MEDISYS 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 | true |
| 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 |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04580262010352 [Primary] |
| JIX | Calibrator, Multi-Analyte Mixture |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2019-09-30 |
| 04580262010314 - Calibrator 2 | 2023-12-26 |
| 04580262010321 - Cleaning Solution | 2023-12-26 |
| 04580262040076 - Calibrator 2 | 2023-12-19 |
| 04580262049802 - IMMTOX 270 | 2021-12-06 IMMTOX 270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures |
| 04580262049819 - DZ-Lite c270 | 2021-12-06 DZ-Lite c270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedur |
| 04580262049826 - MyeLyte Touch | 2021-12-06 MyeLyte Touch is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedu |
| 04580262010208 - Alkaline Washing Solution | 2019-12-23 |
| 04580262010222 - Acid Washing Solution | 2019-12-23 |