Primary Device ID | 07898959841750 |
NIH Device Record Key | 8fa494ef-0dd9-4d8d-aeb4-0b9ea68b42e8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ENLIGHT ELECTRODE ADDERE - SIZE M |
Version Model Number | ACE-00032 |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07898959841750 [Unit of Use] |
GS1 | 07898966433276 [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 |
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 |
07898959841002 - ENLIGHT BELT - 5S - LEFT | 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex- |
07898959841873 - ENLIGHT BELT - XXS - RIGHT | 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex- |
07898959841880 - ENLIGHT BELT - XXS - LEFT | 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex- |
07898959841897 - ENLIGHT BELT - XS - RIGHT | 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex- |
07898959841903 - ENLIGHT BELT - XS - LEFT | 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex- |
07898959841910 - ENLIGHT BELT - S - RIGHT | 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex- |
07898959841927 - ENLIGHT BELT - S - LEFT | 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex- |