Body Composition Dual Tab Electrode 292-BCE

GUDID B277292BCE2

Body Composition Dual Tab Electrode, each pouch contains 60 single use gel backed electrodes.

IMPEDIMED LIMITED

Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use
Primary Device IDB277292BCE2
NIH Device Record Key1ee3eac9-1f5e-4384-b37f-c8971d367248
Commercial Distribution StatusIn Commercial Distribution
Brand NameBody Composition Dual Tab Electrode
Version Model Number292-BCE
Catalog Number292-BCE
Company DUNS757258843
Company NameIMPEDIMED LIMITED
Device Count60
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+61738603700
EmailXX@XX.XXX
Phone+61738603700
EmailXX@XX.XXX

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB277292BCE0 [Unit of Use]
HIBCCB277292BCE1 [Primary]
HIBCCB277292BCE2 [Package]
Contains: B277292BCE1
Package: Shipper [10 Units]

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-02-13

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