ENLIGHT PATIENT REFERENCE CABLE

GUDID 07898959841729

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 ID: 07898959841729
• NIH Device Record Key: e161db32-9a66-4aaa-8d2b-d1cf40197703
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENLIGHT PATIENT REFERENCE CABLE
• Version Model Number: DX-0TC03
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com
• Phone: +551130880305
• Email: qualidade@timpelmedical.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07898959841729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170072

FDA Product Code

• QEB: Ventilatory Electrical Impedance Tomograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-05
• Device Publish Date: 2019-10-28

On-Brand Devices [ENLIGHT PATIENT REFERENCE CABLE]

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