| Primary Device ID | 00856298006435 |
| NIH Device Record Key | 4bf3c307-f344-425a-a921-b3bd6babb461 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EZLink-C |
| Version Model Number | EZLink-C |
| Catalog Number | 103200 |
| 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 | 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 | |
| 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 | |
| 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 | 00856298006435 [Primary] |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-31 |
| Device Publish Date | 2024-05-23 |
| 00856298006428 - EZLink-R | 2024-05-31 |
| 00856298006435 - EZLink-C | 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. |