| Primary Device ID | 00850010298061 |
| NIH Device Record Key | dfa4beb4-f93c-47c2-b9b0-92355835dd53 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eko Mobile App Android International |
| Version Model Number | com.ekodevices.android.intl |
| 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 | true |
| Serial Number | true |
| 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 | 00850010298061 [Primary] |
| OUG | Medical Device Data System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-20 |
| Device Publish Date | 2021-04-12 |
| 00850010298726 - CORE 500 Digital Stethoscope - Electric Pink Chestpiece | 2025-08-20 CORE 500 Digital Stethoscope - Electric Pink Chestpiece |
| 00850010298757 - CORE 500 Digital Stethoscope - Electric Pink Earpiece | 2025-08-20 CORE 500 Digital Stethoscope - Electric Pink Earpiece |
| 00850010298788 - CORE 500 Digital Stethoscope - Bundle-SLV | 2025-08-20 CORE 500 Digital Stethoscope - Bundle-SLV |
| 00850010298795 - CORE 500 Digital Stethoscope - Bundle-BLK | 2025-08-20 CORE 500 Digital Stethoscope - Bundle-BLK |
| 00850010298801 - CORE 500 Digital Stethoscope - Bundle-CHP | 2025-08-20 CORE 500 Digital Stethoscope - Bundle-CHP |
| 00850010298818 - CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club Pink | 2025-08-20 CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club Pink |
| 00850010298733 - CORE 500 Digital Stethoscope - Ruby Earpiece | 2025-03-27 CORE 500 Digital Stethoscope - Ruby Earpiece |
| 00850010298245 - CORE 500 Digital Stethoscope FIGS Earpiece - Black | 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Black |