| Primary Device ID | 00863609000334 |
| NIH Device Record Key | 0dc24928-1f99-41c6-9674-8e12da00e124 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eko Mobile App iOS |
| Version Model Number | 3.1.1 |
| 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 | 00863609000334 [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 |
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