| Primary Device ID | 00850047782007 |
| NIH Device Record Key | 776dd86a-db95-4337-a2e6-7a77f5b4ed80 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel") |
| Version Model Number | ES-2 |
| Catalog Number | JWL1-MDU0-E-01 |
| Company DUNS | 079801768 |
| Company Name | Element Science, Inc. |
| 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 | false |
| Expiration Date | true |
| 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 | 00850047782007 [Primary] |
| MVK | Wearable Automated External Defibrillator |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-20 |
| Device Publish Date | 2025-05-12 |
| 00850047782007 - Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel") | 2025-05-20ES-2 Reusable Defibrillator Unit, Packaged (900-00032) |
| 00850047782007 - Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel") | 2025-05-20 ES-2 Reusable Defibrillator Unit, Packaged (900-00032) |
| 00850047782038 - Jewel Starter Kit | 2025-05-20 ES-2 Starter Kit, Finished, Packaged (Hair Trimmer, Placement Accessory, Adhesive Sheets, Patient Guide) (900-00036) |
| 00850047782090 - Jewel Patch | 2025-05-20 Adhesive Electrode Patch (ES-2) (900-00031) |