FDA.reportPublic FDA data

Single Tab Electrode

Primary DI
B277292STE1
Brand
Single Tab Electrode
Company
IMPEDIMED LIMITED
Model
292-STE
Catalog number
292-STE
Device description
Single Tab Electrode, each pouch contains 100 single use gel backed electrodes.
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B277292STE2PackageHIBCC10
B277292STE1PrimaryHIBCC0
B277292STE0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
760 585 2100XX@XX.XXX
+61738603700XX@XX.XXX

Regulatory Flags#

DUNS number
757258843
Device count
100
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
B277292U400CD0U400 ImpSoft Software2.2.0292-U400CD2017-02-13
B277299SFB7CD0BioImp Body Composition Analysis Software SFB7 5.5.0.1299-SFB7CD2017-02-13

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Primary DI, Brand, Company table
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