| Primary Device ID | 07898966433184 |
| NIH Device Record Key | 52b2382a-a2e1-4a9f-b837-688f0b18d445 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENLIGHT BELT - S - RIGHT |
| Version Model Number | ACE-00024 |
| Company DUNS | 897939320 |
| Company Name | Timpel S/A |
| 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 | 07898966433184 [Primary] |
| QEB | Ventilatory Electrical Impedance Tomograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-18 |
| Device Publish Date | 2021-05-10 |
| 07898959841668 | The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom |
| 07898966433184 | The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom |
| 07898959841910 | The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom |