| Primary Device ID | 06944413808164 |
| NIH Device Record Key | a238a7dc-8e5e-4ea7-9f4a-e9badb5d220a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | TM-400 Treadmill |
| 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 | 06944413808164 [Primary] |
| IOL | Treadmill, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-12-07 |
| 06944413820463 - Holter ECG and ABP System | 2023-12-08 |
| 06944413820470 - Holter ECG and ABP System | 2023-12-08 |
| 06944413820487 - Holter ECG and ABP System | 2023-12-08 |
| 06944413820494 - Holter ECG and ABP System | 2023-12-08 |
| 06944413820500 - Holter ECG and ABP System | 2023-12-08 |
| 06944413820562 - Electrocardiograph | 2023-12-08 |
| 06944413820616 - Electrocardiograph | 2023-12-08 |
| 06944413812680 - Ambulatory Blood Pressure Monitor | 2023-06-29 |