| Primary Device ID | B618B0 |
| NIH Device Record Key | a875ef0c-a8cd-4b66-b716-22cc9c4e5c42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Complete Communicator |
| Version Model Number | 1 |
| Company DUNS | 078505297 |
| Company Name | COAPT LLC |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B618B0 [Primary] |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-05-08 |
| E10001 - ControlSeal Electrode Domes (Standard Size) | 2023-12-18 Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG). |
| B618E3 - ControlSeal Electrode Domes (Large Size) | 2023-12-18 Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG). |
| E40001 - ControlSeal Electrode Domes (Standard Size) | 2023-02-28 Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG). |
| E50001 - ControlSeal Electrode Domes (Large Size) | 2023-02-28 Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG). |
| B618Q1 - Coapt Evaluation Kit | 2019-11-26 The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt COMPLETE CONTROL System Gen2. It is |
| B618P1 - Gen2 System Kit | 2019-06-27 The Gen2 System Kit is a medical device kit that contains the Coapt COMPLETE CONTROL System Gen2 (DI=B618N1) and the Coapt Dome |
| B618N1 - COMPLETE CONTROL System Gen2 | 2019-06-20 The COMPLETE CONTROL System Gen2 is an advanced control solution designed to provide the functionality of a powered myoelectric |
| B618E0 - Dome Electrodes | 2019-04-23 Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG). |