ENLIGHT 1810

GUDID 07898959841415

"ENLIGHT 1810 is a non-invasive and non-radiation medical device that provides information from impedance variation from a cross-section of a patient’s thorax. This information is presented to the clinician user as adjunctive tool to be used with other clinical information to assess the patient’s ventilation. It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm. ENLIGHT1810 and its accessories are prescription use only."

Timpel S/A

Thoracic electrical bioimpedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic Thoracic electrical impedance system, tomographic

• Primary Device ID: 07898959841415
• NIH Device Record Key: a47245bc-0069-4c43-91d1-0d216945adc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENLIGHT 1810
• Version Model Number: TP-ENU00-0
• Company DUNS: 897939320
• Company Name: Timpel S/A
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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

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 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07898959841415 [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

Devices Manufactured by Timpel S/A

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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-