MYSOZO.com SFT-025

GUDID B277SFT0250

Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track changes in the fluid state overtime; impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio, that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale.

IMPEDIMED LIMITED

Bioelectrical body composition analyser

• Primary Device ID: B277SFT0250
• NIH Device Record Key: 70332b4b-8d4e-4d6f-9faf-2a72e7a8e794
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MYSOZO.com
• Version Model Number: V 5.0.0
• Catalog Number: SFT-025
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com
• Phone: +61070386003700
• Email: TSU@impedimed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B277SFT0250 [Primary]

FDA Product Code

• DSB: Plethysmograph, Impedance

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: 2023-08-11
• Device Publish Date: 2023-08-03

Devices Manufactured by IMPEDIMED LIMITED

• B277SFT0250 - MYSOZO.com: 2023-08-11Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track changes in the fluid state overtime; impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio, that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale.
• B277SFT0250 - MYSOZO.com: 2023-08-11 Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume diffe
• B277SOZOAPP0 - SOZOapplication: 2023-08-04 Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume diffe
• B27728269951 - SOZO Body Fluid Analyzer: 2022-05-24 SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, mul
• B27727269950 - SOZO Body Fluid Analyzer: 2019-09-20 SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, mul
• B277222LDEXU4002 - L-Dex® U400: 2018-07-06 BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measuremen
• B277223DF502 - Imp DF50: 2018-07-06 DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body compo
• B277223SFB72 - Imp SFB7: 2018-07-06 BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measuremen
• B277229DF502 - Imp DF50: 2018-07-06 DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body compo