SHAPER No.1

GUDID 07898959841262

The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of the patient's chest, if needed. Available in two sizes, biocompatible, non-invasive, non-sterile and not to be sterilized.

Timpel S/A

Thoracic electrical bioimpedance system electrode array positioner

• Primary Device ID: 07898959841262
• NIH Device Record Key: c694b488-5978-4d19-b725-2401c97b02f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHAPER No.1
• Version Model Number: AD-05001
• 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
• 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

• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07898959841262 [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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• 07908715700907 - ENLIGHT ADDERE - 4S: 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
• 07908715700891 - ENLIGHT ADDERE - 5S: 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
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