SOZO Body Fluid Analyzer 2826995

GUDID B27728269951

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor. (Repackaged for use in Clinical evaluations (Trials))

IMPEDIMED LIMITED

Bioelectrical body composition analyser

• Primary Device ID: B27728269951
• NIH Device Record Key: 6f1b62e1-91ae-4c92-bea5-4c6d61a818cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOZO Body Fluid Analyzer
• Version Model Number: 2826995
• Catalog Number: 2826995
• Company DUNS: 757258843
• Company Name: IMPEDIMED LIMITED
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: +61738603700
• Email: enquiries@impedimed.com
• Phone: +61738603700
• Email: enquiries@impedimed.com
• Phone: +61738603700
• Email: enquiries@impedimed.com
• Phone: +61738603700
• Email: enquiries@impedimed.com
• Phone: +61738603700
• Email: enquiries@impedimed.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• 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 Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• 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 Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B27728269950 [Primary]
HIBCC	B27728269951 [Package]; Contains: B27728269950; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172122

FDA Product Code

• OBH: Monitor, Extracellular Fluid, Lymphedema, Extremity

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: 2022-05-24
• Device Publish Date: 2022-05-16

On-Brand Devices [SOZO Body Fluid Analyzer]

• B27727270000: SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time,
• B27725269950: SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, n
• B27724269952: SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, n
• B27727269950: SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time,
• B27728269951: SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time,