| Primary Device ID | 00850725007101 |
| NIH Device Record Key | 25ee5eba-2e2b-41a8-8678-bf08ddc44aeb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LifeWatch Mobile Cardiac Telemetry 3-Lead |
| Version Model Number | MCT 3L-International |
| Company DUNS | 797936734 |
| Company Name | Lifewatch |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-700-3788 |
| DL-CCCSupervisors@lifewatch.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850725007101 [Primary] |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-07 |
| Device Publish Date | 2016-09-16 |
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| 00850725007033 | 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon) |
| 00850725007026 | 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Brigadier/Android/Verizon) |
| 00850725007019 | 3 Lead Continuous ECG Monitor & Arrhythmia Detector (ES400/Windows/Verizon) |
| 00850725007002 | 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Ozone/Windows/Verizon) |