| Primary Device ID | 00856298006091 |
| NIH Device Record Key | 13be01bb-9cb6-4fb3-83a7-020c618f5f39 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Chroma2 5 Lead Patient Cable |
| Version Model Number | Chroma2 5 Lead Patient Cable |
| 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 | true |
| Serial Number | false |
| 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 |
| Phone | 216-362-0550 |
| service@scottcare.com | |
| Phone | 216-362-0550 |
| service@scottcare.com | |
| Phone | 216-362-0550 |
| service@scottcare.com | |
| Phone | 216-362-0550 |
| service@scottcare.com | |
| Phone | 216-362-0550 |
| service@scottcare.com | |
| Phone | 216-362-0550 |
| service@scottcare.com | |
| Phone | 216-362-0550 |
| service@scottcare.com | |
| Phone | 216-362-0550 |
| service@scottcare.com | |
| Phone | 216-362-0550 |
| service@scottcare.com | |
| Phone | 216-362-0550 |
| service@scottcare.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856298006091 [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 | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-19 |
| 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. |
| 00856298006053 - Angel | 2019-05-07 Cardiac Rehab ECG telemetry transmitter. |
| 00856298006060 - Innovo | 2019-05-07 Cardiac Rehab ECG telemetry transmitter. |