Primary Device ID | 07898959841897 |
NIH Device Record Key | 6a3d785c-cb46-4500-a91e-952cec2cc85e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ENLIGHT BELT - XS - RIGHT |
Version Model Number | ACE-0001E-0 |
Company DUNS | 897939320 |
Company Name | Timpel S/A |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
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 | 2023-09-11The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere. |
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- |