Primary Device ID | 07898959841194 |
NIH Device Record Key | a8428e57-57e8-4420-8806-ce4668ebdc7b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ENLIGHT ELECTRODE ADDERE- SIZE M |
Version Model Number | AD-03008 |
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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07898959841194 [Primary] |
GS1 | 07898959841750 [Unit of Use] |
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 | 2019-11-05 |
Device Publish Date | 2019-10-28 |
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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- |