| Primary Device ID | 00856298006305 |
| NIH Device Record Key | a7a06e30-6cd0-418a-b4e0-249de40c66fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TeleRehab Rack Server |
| Version Model Number | TeleRehab Rack Server |
| Catalog Number | 100666 |
| Company DUNS | 808204957 |
| Company Name | SCOTTCARE CORPORATION, THE |
| 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 | 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 |
| Phone | 216-362-0550 |
| service@scottcare.com |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856298006305 [Primary] |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-19 |
| 00856298006428 - EZLink-R | 2024-05-31 |
| 00856298006435 - EZLink-C | 2024-05-31 |
| 00856298006008 - Chroma | 2019-11-08 The Chroma model RZ153C Holter monitor is a battery operated solid-state recorder. It is designed for up to 48 hours (2 days) co |
| 00856298006015 - Chroma2 | 2019-11-08 |
| 00856298006022 - TeleSenseRCM | 2019-11-08 The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events |
| 00856298006039 - TeleSense-E | 2019-11-08 The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events |
| 00856298006220 - Chroma 5 Lead Patient Cable | 2019-11-08 5 lead ECG patient cable to be used with the Chroma device. |
| 00856298006312 - Chroma 7 Lead Patient Cable | 2019-11-08 7 lead ECG patient cable to be used with the Chroma device. |