Imp SFB7 229-SFB7

GUDID B277229SFB72

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and dete

IMPEDIMED LIMITED

Bioelectrical body composition analyser Bioelectrical body composition analyser
Primary Device IDB277229SFB72
NIH Device Record Key00f75b8a-20d3-4c9a-9d37-0f61a3ca6669
Commercial Distribution StatusIn Commercial Distribution
Brand NameImp SFB7
Version Model NumberSFB7
Catalog Number229-SFB7
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+61738603700
Emailxx@xx.xx
Phone+61738603700
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB277229SFB70 [Primary]
HIBCCB277229SFB71 [Package]
Contains: B277229SFB70
Package: Soft Carry Case [1 Units]
HIBCCB277229SFB72 [Package]
Contains: B277229SFB71
Package: Shipper [1 Units]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNWAnalyzer, Body Composition

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

On-Brand Devices [Imp SFB7]

B277259SFB72BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-
B277253SBF72BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-
B277249SFB70BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-
B277243SFB72BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-
B277229SFB72BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-
B277223SFB72BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-

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