FDA.reportPublic FDA data

L-Dex® U400

Primary DI
B277242LDEXU4002
Brand
L-Dex® U400
Company
IMPEDIMED LIMITED
Model
U400
Catalog number
242-LDEXU400
Device description
BIS Extra Cellular Fluid Analysis- refurbished. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by appl
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBHMonitor, Extracellular Fluid, Lymphedema, Extremity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBHMonitor, Extracellular Fluid, Lymphedema, ExtremityCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130338000IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSISImpediMed Limited2013-05-31OBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B277242LDEXU4001PackageHIBCC1
B277242LDEXU4002PackageHIBCC1
B277242LDEXU4000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61738603700XX@XX.com

Regulatory Flags#

DUNS number
757258843
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B277222LDEXU4000L-Dex® U400U400222-LDEXU4002017-02-13
B277223DF500Imp DF50DF50223-DF502017-02-13
B277223SFB70Imp SFB7SFB7223-SFB72017-02-13
B277229DF500Imp DF50DF50229-DF502017-02-13
B277229SFB70Imp SFB7SFB7229-SFB72017-02-13
B27724269950SOZO Body Fluid Analyzer2426995242-SOZO2018-05-01
B277242LDEXU4000L-Dex® U400U400242-LDEXU4002017-02-13
B277243DF500Imp DF50DF50229-DF502017-02-13
B277243SFB70Imp SFB7SFB7243-SFB72017-02-13
B277249DF500Imp DF50DF50229-DF502017-02-13
B277252LDEXU4000L-Dex® U400U400242-LDEXU4002017-02-13
B277253DF500Imp DF50DF50229-DF502017-02-13
B277253SFB70Imp SFB7SFB7253-SFB72017-02-13
B277259DF500Imp DF50DF50229-DF502017-02-13
B277259SFB70Imp SFB7 SFB7259-SFB72017-02-13
B27728269950SOZO Body Fluid Analyzer282699528269952022-05-16
B277292BCE1Body Composition Dual Tab Electrode292-BCE292-BCE2017-02-13
B277292DF50CD0Body Composition Analysis Software4.1.2292-DF50CD2017-02-13
B277292STE1Single Tab Electrode292-STE292-STE2017-02-13
B277292U400CD0U400 ImpSoft Software2.2.0292-U400CD2017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B277SFT0250MYSOZO.com IMPEDIMED LIMITEDOBH2023-08-03
B27728269950SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2022-05-16
B27728269951SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2022-05-16
B27727269950SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2019-09-12
B277SOZOAPP0SOZOapplicationIMPEDIMED LIMITEDOBH2019-08-01
B27724269950SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2018-05-01
B27724269952SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2018-05-01
B27725269950SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2018-05-01
B27727270000SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2017-10-02
B277SOZOTHRIVE0SOZOThriveIMPEDIMED LIMITEDOBH2017-10-02
B277222LDEXU4000L-Dex® U400IMPEDIMED LIMITEDOBH2017-02-13
B277242LDEXU4000L-Dex® U400IMPEDIMED LIMITEDOBH2017-02-13
B277252LDEXU4000L-Dex® U400IMPEDIMED LIMITEDOBH2017-02-13
B277292U400CD0U400 ImpSoft SoftwareIMPEDIMED LIMITEDOBH2017-02-13
B277222LDEXU4002L-Dex® U400IMPEDIMED LIMITEDOBH2017-02-13
B227252LDEXU4002L-Dex® U400IMPEDIMED LIMITEDOBH2017-02-13
B277292U400CD2U400 ImpSoft SoftwareIMPEDIMED LIMITEDOBH2017-02-13