SOZO Body Fluid Analyzer 242-SOZO

GUDID B27724269952

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measuremen

IMPEDIMED LIMITED

Bioelectrical body composition analyser Bioelectrical body composition analyser
Primary Device IDB27724269952
NIH Device Record Keyece748c4-d2f0-4b5a-86a1-a5722f4fdca0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOZO Body Fluid Analyzer
Version Model Number2426995
Catalog Number242-SOZO
Company DUNS757258843
Company NameIMPEDIMED LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+61738603700
EmailEnquiries@impedimed.com
Phone+61738603700
EmailEnquiries@impedimed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB27724269950 [Primary]
HIBCCB27724269951 [Package]
Contains: B27724269950
Package: Carton [1 Units]
In Commercial Distribution
HIBCCB27724269952 [Package]
Contains: B27724269951
Package: Outer Shipper [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBHMonitor, Extracellular Fluid, Lymphedema, Extremity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-01

On-Brand Devices [SOZO Body Fluid Analyzer]

B27727270000SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time,
B27725269950SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, n
B27724269952SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, n
B27727269950SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time,
B27728269951SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time,

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