| Primary Device ID | 00195278341129 |
| NIH Device Record Key | 0fd149d2-0ddd-4595-8b55-43d2bcaabd51 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Portrait CSS01 |
| Version Model Number | CSS01 |
| Catalog Number | 5870857 |
| Company DUNS | 006580799 |
| Company Name | GE MEDICAL SYSTEMS INFORMATION 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00195278341129 [Primary] |
| MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-11 |
| Device Publish Date | 2023-09-01 |
| 00195278364661 - CardioSoft | 2025-04-02 CARDIOSOFT V7.0 SP7.2 |
| 00195278403643 - CASE | 2025-04-02 CASE V7.0 |
| 00195278617644 - CASE | 2025-04-02 CASE V7 GENERIC ATO |
| 00840682144322 - MAC | 2025-03-21 MAC 7 |
| 00195278457547 - ALGORITHM SERVICES | 2025-03-13 ALGORITHM SERVICES EK12 V2 |
| 00195278990945 - Mural Clinical Viewer | 2025-02-28 MD Mural Clinical Viewer 1.3 MEDICAL DEVICE |
| 00195278726391 - MURAL PERINATAL SURVEILLANCE | 2024-06-10 MD MURAL PERINATAL SURVEILLANCE 2.2 MEDICAL DEVICE |
| 00195278561312 - Portrait VSM | 2024-05-13 Portrait VSM ATO MODEL |