TONOPORT VI

GUDID 04260671371021

PAR Medizintechnik GmbH & Co. Kommanditgesellschaft

Blood pressure ambulatory recorder

• Primary Device ID: 04260671371021
• NIH Device Record Key: 4bbbd039-4571-46f6-ba93-66b823a5f9b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TONOPORT VI
• Version Model Number: 2001589-202
• Company DUNS: 324233626
• Company Name: PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: +49302350700
• Email: info@par-berlin.com
• Phone: +49302350700
• Email: info@par-berlin.com
• Phone: +49302350700
• Email: info@par-berlin.com
• Phone: +49302350700
• Email: info@par-berlin.com
• Phone: +49302350700
• Email: info@par-berlin.com
• Phone: +49302350700
• Email: info@par-berlin.com
• Phone: +49302350700
• Email: info@par-berlin.com
• Phone: +49302350700
• Email: info@par-berlin.com
• Phone: +49302350700
• Email: info@par-berlin.com
• Phone: +49302350700
• Email: info@par-berlin.com
• Phone: +49302350700
• Email: info@par-berlin.com
• Phone: +49302350700
• Email: info@par-berlin.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260671371021 [Primary]

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2024-12-20
• Device Publish Date: 2024-12-12