| Primary Device ID | 25060484630031 |
| NIH Device Record Key | 15ae9471-73f7-4ad1-a443-5951eb63abd1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aingeal 3-patch electrode |
| Version Model Number | PN1120 |
| Company DUNS | 231959888 |
| Company Name | INTELESENS LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060484630037 [Primary] |
| GS1 | 15060484630034 [Package] Contains: 05060484630037 Package: Foil pouch [4 Units] In Commercial Distribution |
| GS1 | 25060484630031 [Package] Contains: 15060484630034 Package: Box [25 Units] In Commercial Distribution |
| MLN | Electrode, Electrodcardiograph, Multi-Function |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-02-01 |
| 15060484630089 - ZENSOR | 2019-02-07 The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system con |
| 05060484630099 - Zensor electrode | 2019-01-21 The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three |
| 15060484630003 - ZENSOR | 2018-07-06 The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system con |
| 05060484630044 - Zensoronline software | 2018-07-06 The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' |
| 05060484630051 - Zensor+ software | 2018-07-06 The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' |
| 15060484630010 - Zensor electrode | 2018-06-14 The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three |
| 05060484630020 - Aingeal | 2018-03-29 The Intelesens Aingeal is used to monitor and transmit physiological data to a remote application for display or analysis by a c |
| 25060484630031 - Aingeal 3-patch electrode | 2018-03-29The Aingeal 3-Patch Electrode Array is an electrocardiograph (ECG), respiration and temperature electrode. It is a disposable, pre-gelled, self-adhesi |
| 25060484630031 - Aingeal 3-patch electrode | 2018-03-29 The Aingeal 3-Patch Electrode Array is an electrocardiograph (ECG), respiration and temperature electrode. It is a disposable, p |