FDA.report

BIA Subject Cables

Primary DI
B202SCLEM60
Brand
BIA Subject Cables
Company
R.J.L. SCIENCES, INC.
Model
LEMO Subject Cables (6 ft)
Catalog number
SCLEM6
Device description
LEMO Subject Cables (6 ft / 1.8 m Length)
Published
2018-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IKDCable, Electrode

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B202SCLEM60PrimaryHIBCC0

GMDN Terms

TermDefinition
Analytical non-scalp cutaneous leadAn insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-528-4513cs@rjlsystems.com

Regulatory Flags

DUNS number
021842273
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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B202Q70RJL QuantumQuantum 7Q72023-08-22
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
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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