FDA.report

BIA Electrodes

Primary DI
B202925004
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
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications

CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B202925002PackageHIBCC2In Commercial Distribution
B202925003PackageHIBCC5In Commercial Distribution
B202925004PackageHIBCC10In Commercial Distribution
B202925001PrimaryHIBCC0
B20292500Unit of UseHIBCC0

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
586-790-0200support@rjlsystems.com

Regulatory Flags

DUNS number
021842273
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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B202QDT0RJL QuantumQuantum DesktopQDT2017-02-01
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