| Primary Device ID | 00853023006159 |
| NIH Device Record Key | 1b855576-781e-4267-a260-4e583c114167 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NOVIUS Lab |
| Version Model Number | 27.2.2 |
| Company DUNS | 042410688 |
| Company Name | CERNER CORPORATION |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853023006159 [Primary] |
| JQP | Calculator/Data Processing Module, 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 | 2018-03-29 |
| Device Publish Date | 2018-02-14 |
| 00850017753136 - FetaLink+ | 2025-07-11 |
| 00850017753129 - FetaLink | 2025-04-29 |
| 00850017753112 - FetaLink+ | 2024-06-03 |
| 00850017753037 - Cerner Patient Observer | 2020-12-22 |
| 00853023006241 - Cerner Patient Observer | 2020-02-10 |
| 00853023006197 - Cerner Patient Observer | 2019-10-08 |
| 00853023006203 - Cerner Patient Observer | 2019-10-08 |
| 00853023006234 - Cerner Patient Observer | 2019-10-08 |