L-Dex® U400 222-LDEXU400

GUDID B277222LDEXU4002

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 IDB277222LDEXU4002
NIH Device Record Key1ffab1e6-d760-48ab-8a36-8eef35c56ee9
Commercial Distribution StatusIn Commercial Distribution
Brand NameL-Dex® U400
Version Model NumberU400
Catalog Number222-LDEXU400
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB277222LDEXU4000 [Primary]
HIBCCB277222LDEXU4001 [Package]
Contains: B277222LDEXU4000
Package: Soft Carry Case [1 Units]
HIBCCB277222LDEXU4002 [Package]
Contains: B277222LDEXU4001
Package: Shipper [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

On-Brand Devices [L-Dex® U400]

B227252LDEXU4002BIS Extra Cellular Fluid Analysis- refurbished. It is designed to provide real-time, noninvasiv
B277242LDEXU4002BIS Extra Cellular Fluid Analysis- refurbished. It is designed to provide real-time, noninvasiv
B277222LDEXU4002BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-

Trademark Results [L-Dex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
L-DEX
L-DEX
77208617 3678241 Live/Registered
ImpediMed Limited
2007-06-18

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