| Primary Device ID | 00811403015771 |
| NIH Device Record Key | 97cb7076-9950-4e8d-b73c-5921e4d3f57f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tubing Kit |
| Version Model Number | ME-2100D |
| Company DUNS | 947514303 |
| Company Name | Diamond Diagnostics Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811403015771 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-21 |
| Device Publish Date | 2023-06-13 |
| 00811403010158 - Photometer Lamp | 2023-06-21 |
| 00811403010240 - Reference Solution | 2023-06-21 |
| 00811403013074 - Pump Tubing Kit | 2023-06-21 |
| 00811403013173 - C1/C2 Cleaning Solution | 2023-06-21 |
| 00811403010387 - Wash Pack | 2023-06-21 |
| 00811403013296 - pH Electrode | 2023-06-21 |
| 00811403013302 - Calcium Electrode | 2023-06-21 |
| 00811403013319 - Potassium Electrode | 2023-06-21 |