Primary Device ID | 07898959841743 |
NIH Device Record Key | 6d3e5c72-1c6f-43da-acae-379297a504cd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ENLIGHT ELECTRODE ADDERE - SIZE S |
Version Model Number | ACE-00031 |
Company DUNS | 897939320 |
Company Name | Timpel S/A |
Device Count | 2 |
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 | 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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07898959841743 [Unit of Use] |
GS1 | 07898966433269 [Primary] |
QEB | Ventilatory Electrical Impedance Tomograph |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-05-18 |
Device Publish Date | 2021-05-10 |
07908715700914 - ENLIGHT ADDERE - XXS | 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the |
07908715700969 - ENLIGHT ADDERE - XL | 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the |
07908715700860 - ENLIGHT ADDERE - P0 | 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the |
07908715700877 - ENLIGHT ADDERE - P1 | 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the |
07908715700884 - ENLIGHT ADDERE - P2 | 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the |
07908715700907 - ENLIGHT ADDERE - 4S | 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the |
07908715700891 - ENLIGHT ADDERE - 5S | 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the |
07898966433146 - ENLIGHT 2100 | 2024-01-03 ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cro |