FDA.reportPublic FDA data

BIA Electrodes

Primary DI
B202925001
Brand
BIA Electrodes
Company
R.J.L. SCIENCES, INC.
Model
92500
Catalog number
92500P
Device description
Package contains 100 adhesive electrodes, sufficient for performing 25 BIA tests for whole-body body composition analysis.
Published
2017-02-01
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
B202925002PackageHIBCC2In Commercial Distribution
B202925003PackageHIBCC5In Commercial Distribution
B202925004PackageHIBCC10In Commercial Distribution
B202925001PrimaryHIBCC0
B20292500Unit 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.

Contacts#

Phone, Email table
PhoneEmail
586-790-0200support@rjlsystems.com
1-800-528-4513support@rjlsystems.com

Regulatory Flags#

DUNS number
021842273
Device count
100
Premarket 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
B202SC6PIN100BIA Subject Cables6-Pin Subject Cables (10 ft)SC6PIN102018-04-24
B202SC6PIN60BIA Subject Cables6-Pin Subject Cables (6 ft)SC6PIN62018-04-24
B202SC6PIN80BIA Subject Cables6-Pin Subject Cables (8 ft)SC6PIN82018-04-24
B202SCLEM60BIA Subject CablesLEMO Subject Cables (6 ft)SCLEM62018-04-24
B202Q70RJL QuantumQuantum 7Q72023-08-22
B202QL0RJL QuantumQuantum LegacyQL2019-08-06
B202BC0BCBC (Body Composition Software)BC2017-08-10
B202BCSEG0BCBC (Body Composition Software) SegmentalBCSEG2017-08-10
B202Q20RJL QuantumQuantum-IIQ22017-02-01
B202Q30RJL QuantumQuantum-IIIQ32017-02-01
B202Q40RJL QuantumQuantum-IVQ42017-02-01
B202Q50RJL QuantumQuantum-VQ52017-02-01
B202Q5S0RJL QuantumQuantum-V SegmentalQ5S2017-02-01
B202QDT0RJL QuantumQuantum DesktopQDT2017-02-01
B202QX0RJL QuantumQuantum-XQX2017-02-01
B202925004BIA Electrodes9250092500P2017-02-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17
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