| Primary Device ID | 6944413808324 |
| NIH Device Record Key | d1112711-0a53-4c34-b68f-8f4e273048bb |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | Smart ECG Broker |
| Company DUNS | 529173163 |
| Company Name | Edan Instruments, 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 | 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 | 06944413808126 [Primary] |
| GS1 | 6944413808324 [Package] Contains: 06944413808126 Package: [10 Units] In Commercial Distribution |
| NSX | Software, Transmission And Storage, Patient Data |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-08 |
| Device Publish Date | 2016-12-03 |
| 06944413815889 - Patient Monitor | 2024-06-25 |
| 06944413815896 - Patient Monitor | 2024-06-25 |
| 06944413815902 - Patient Monitor | 2024-06-25 |
| 06944413813977 - ECG cable | 2024-06-06 |
| 06944413813984 - ECG cable | 2024-06-06 |
| 06944413813991 - ECG cable | 2024-06-06 |
| 06944413814004 - ECG cable | 2024-06-06 |
| 06944413814011 - ECG cable | 2024-06-06 |