ENLIGHT PATIENT REFERENCE CABLE

GUDID 07898966433290

The reference cable is connected to a common ECG-like electrode applied to the patient to acquire reference signal of electric impedance data. The accessory has been developed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized.

Timpel S/A

Analytical non-scalp cutaneous lead
Primary Device ID07898966433290
NIH Device Record Key631bec36-9096-4b05-aca0-94cc67d624c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameENLIGHT PATIENT REFERENCE CABLE
Version Model NumberACE-00034
Company DUNS897939320
Company NameTimpel S/A
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107898966433290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEBVentilatory Electrical Impedance Tomograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-18
Device Publish Date2021-05-10

On-Brand Devices [ENLIGHT PATIENT REFERENCE CABLE]

07898959841729The reference cable is connected to a common ECG-like electrode applied to the patient to acquir
07898966433290The reference cable is connected to a common ECG-like electrode applied to the patient to acquir

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