| Primary Device ID | 00863609000358 |
| NIH Device Record Key | 9e7c0a88-0c68-4a22-bc19-a34825397c47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eko App Windows |
| Version Model Number | 1.2.4 |
| Company DUNS | 079670921 |
| Company Name | EKO DEVICES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00863609000358 [Primary] |
| OUG | Medical Device Data System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2018-08-16 |