| Primary Device ID | 06944413801554 |
| NIH Device Record Key | b839b6cc-37c9-458d-9dee-efc296bf02ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Electrocardiograph |
| Version Model Number | SE-1201 |
| Company DUNS | 529173163 |
| Company Name | Edan Instruments, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 06944413801554 [Primary] |
| DPS | Electrocardiograph |
| 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 | 2016-09-01 |
| 06944413808980 | SL18A |
| 06944413808966 | SL12A |
| 06944413807921 | ECG-3F Plus |
| 06944413807792 | ECG-1201 |
| 06944413807761 | ECG-1200 |
| 06944413807754 | ECG-1200 Plus |
| 06944413807747 | ECG-12 B |
| 06944413806979 | ECG-3F |
| 06944413806962 | ECG-3 |
| 06944413806955 | ECG-3 Plus |
| 06944413806931 | ECG-12C |
| 06944413806924 | ECG-12 |
| 06944413806917 | ECG-12 Plus |
| 06944413806900 | ECG-6 Pro |
| 06944413806894 | ECG-6 Plus |
| 06944413806887 | ECG-6 |
| 06944413806870 | SL6A |
| 06944413802520 | SE-301 |
| 06944413802216 | SE-18 |
| 06944413801554 | SE-1201 |
| 06944413800724 | SE-601C |
| 06944413800717 | SE-601B |
| 06944413800700 | SE-601A |
| 06944413800380 | SE-1200 Express |
| 06944413800373 | SE-1200 |
| 06944413800366 | SE-12 Express |
| 06944413800359 | SE-12 |
| 06944413800342 | SE-600 |
| 06944413800335 | SE-6 |
| 06944413800328 | SE-300B |
| 06944413800311 | SE-300A |
| 06944413800304 | SE-3 |
| 06944413800298 | SE-3 |
| 06944413812857 | SE-1202 |
| 06944413820616 | SE-1200Pro |
| 06944413820562 | SE-1201Pro |