| Primary Device ID | 00863609000327 |
| NIH Device Record Key | 970b4038-8e07-4c14-8ede-21ac9fec8def |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUO |
| Version Model Number | E5 |
| Company DUNS | 079670921 |
| Company Name | EKO DEVICES, 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 | 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 | 00863609000327 [Primary] |
| DPS | Electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-16 |
| Device Publish Date | 2018-07-16 |