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 Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical bioimpedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance electrode array positioner Thoracic electrical impedance 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

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