U400 ImpSoft Software 292-U400CD

GUDID B277292U400CD2

Impsoft data management & analysis software

IMPEDIMED LIMITED

Bioelectrical body composition analyser Bioelectrical body composition analyser
Primary Device IDB277292U400CD2
NIH Device Record Key23776b58-b860-4ea9-ab8c-f1454c5f8082
Commercial Distribution StatusIn Commercial Distribution
Brand NameU400 ImpSoft Software
Version Model Number2.2.0
Catalog Number292-U400CD
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB277292U400CD0 [Primary]
HIBCCB277292U400CD1 [Package]
Contains: B277292U400CD0
Package: CD Label [1 Units]
HIBCCB277292U400CD2 [Package]
Contains: B277292U400CD1
Package: CD Sleeve [1 Units]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-13

Devices Manufactured by IMPEDIMED LIMITED

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B27727269950 - SOZO Body Fluid Analyzer2019-09-20 SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, mul
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B277223DF502 - Imp DF502018-07-06 DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body compo
B277223SFB72 - Imp SFB72018-07-06 BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measuremen
B277229DF502 - Imp DF502018-07-06 DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body compo

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