| Primary Device ID | 00840682140485 |
| NIH Device Record Key | 98681576-f3f8-4f20-83f1-59ffb79fce12 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | ECG Leadwire set, telemetry, 5-lead, grabber, AHA, |
| Catalog Number | 2107243-003 |
| Company DUNS | 401966697 |
| Company Name | GE Healthcare Finland Oy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | 00840682140485 [Primary] |
| IKD | CABLE, ELECTRODE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-08 |
| Device Publish Date | 2019-02-05 |
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| 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 |
| 00195278201980 - PORTRAIT AAB01 | 2023-09-11 Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS |
| 00195278264794 - PORTRAIT SpO2 P-SP01 | 2023-09-11 PORTRAIT SpO2 P-SP FINAL DEVICE ASSEMBLY |