| Primary Device ID | 00840682104128 |
| NIH Device Record Key | f83e31a5-58ba-4f16-9bd9-eb917baaf5b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | E-PT-00 |
| Company DUNS | 401966697 |
| Company Name | GE Healthcare Finland Oy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
| Phone | +1(800)558-5120 |
| xx@xx.xx |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682104128 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-03 |
| 00195278697165 - PORTRAIT HSWXB | 2024-05-08 Portrait HSWXB Medical Software |
| 00195278713193 - Portrait HUBXB | 2024-05-08 Portrait Mobile Patient Monitor Hardware HUBXB |
| 00195278229229 - PORTRAIT RRP01 | 2024-01-03 BODY-WORN RESP ELECTRODE PATCH |
| 00195278699916 - PORTRAIT AAB01 | 2023-11-03 Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS |
| 00195278699923 - PORTRAIT MMP01 | 2023-11-03 Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS |
| 00195278093998 - PORTRAIT HUB01 | 2023-09-11 HUB, AMBULATORY HUB DEVICE ASSEMBLY |
| 00195278094001 - PORTRAIT BCH01 | 2023-09-11 CHARGER, AMBULATORY CHARGER FINAL DEVICE ASSEMBLY |
| 00195278110435 - PORTRAIT MMP01 | 2023-09-11 Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS |