| Primary Device ID | 00195278697165 |
| NIH Device Record Key | 8727f277-8bcc-44ae-96b5-7720893e5226 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PORTRAIT HSWXB |
| Version Model Number | HSWXB |
| Catalog Number | 5700219-11 |
| Company DUNS | 401966697 |
| Company Name | GE Healthcare Finland Oy |
| 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 | 00195278697165 [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 | 2024-05-08 |
| Device Publish Date | 2024-04-30 |
| 00195278697165 - PORTRAIT HSWXB | 2024-05-08Portrait HSWXB Medical Software |
| 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 |