Imp DF50 229-DF50

GUDID B277229DF502

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare

IMPEDIMED LIMITED

Bioelectrical body composition analyser Bioelectrical body composition analyser
Primary Device IDB277229DF502
NIH Device Record Key6b7d5399-ba36-438f-8055-203f85d547ee
Commercial Distribution Discontinuation2017-02-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameImp DF50
Version Model NumberDF50
Catalog Number229-DF50
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB277229DF500 [Primary]
HIBCCB277229DF501 [Package]
Contains: B277229DF500
Package: Soft Carry Case [1 Units]
Discontinued: 2017-02-13
Not in Commercial Distribution
HIBCCB277229DF502 [Package]
Contains: B277229DF501
Package: Shipper [1 Units]
Discontinued: 2017-02-13
Not in Commercial Distribution

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 DF50]

B277259DF502DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessmen
B277253DF502DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessmen
B277249DF502DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessmen
B277243DF502DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessmen
B277229DF502DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessmen
B277223DF502DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessmen

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