FDA.reportPublic FDA data

Imp SFB7

Primary DI
B277253SBF72
Brand
Imp SFB7
Company
IMPEDIMED LIMITED
Model
SFB7
Catalog number
253-SFB7
Device description
BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and dete
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNWAnalyzer, Body Composition

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNWAnalyzer, Body CompositionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052319000IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7Impedimed Pty , Ltd.2006-04-04MNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B277253SBF71PackageHIBCC1
B277253SBF72PackageHIBCC1
B277253SFB70PrimaryHIBCC0

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

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Primary DI, Brand, Company table
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20077784049192TAYLORTAYLOR PRECISION PRODUCTS, INC.MNW2025-05-06
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