| Primary Device ID | 00840682123662 |
| NIH Device Record Key | 16b49c07-71c6-4488-a892-43e364218d4f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | D4 MAS GOLDSEAL |
| Company DUNS | 784985108 |
| 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 | false |
| Serial Number | true |
| 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 | 00840682123662 [Primary] |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2017-04-11 |
| 00840682188968 - MLCL Upgrade | 2025-04-21 Upgrade Kit MLCL V7.1 |
| 00840682124669 - NA | 2025-04-18 ASSY CARESCAPE ONE NIBP HOSE NEONATAL 2T NEO-SNAP 2.4M |
| 00840682124683 - NA | 2025-04-18 ASSY CARESCAPE ONE NIBP HOSE NEONATAL 2T NEO-SNAP 3.6M |
| 00195278421449 - CAM | 2025-04-15 CAM 14 - MDR |
| 00195278421456 - CAM | 2025-04-15 CAM HD - MDR |
| 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 |