FDA.reportPublic FDA data

Rhythmlink®

Primary DI
00816312025552
Brand
Rhythmlink®
Company
RHYTHMLINK INTERNATIONAL, LLC
Model
293-2-36STP
Device description
Reusable Ring Electrode, EMG, 36 inch Shielded Leadwire
Published
2021-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816312025552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816312025552008163120255528163120255520816312025552

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
8666333754xx@xx.xx

Regulatory Flags#

DUNS number
126290993
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816312027969Rhythmlink®DC31152026-02-13
00816312027921Rhythmlink®MRQD31006101522025-12-08
10816312027850Rhythmlink®CTGN2121-2.52025-12-05
10816312027867Rhythmlink®CTGN2121-2.52025-12-03
00816312027792Rhythmlink®MRSWB14152025-09-29
10816312027805Rhythmlink®MRQSWB20908152025-09-24
10816312027812Rhythmlink®MRQD3080807152025-09-05
00816312027365Rhythmlink®GNFD5152025-07-30
00816312027372Rhythmlink®GNFD51522025-07-30
00816312027785Rhythmlink®CTDC2615202025-07-24
00816312027761Rhythmlink®DC21152025-07-23
00816312027778Rhythmlink®DC271522025-07-23
00816312027709Rhythmlink®RLSP5522025-05-16
00816312027716Rhythmlink®RLSP5532025-05-16
00816312027723Rhythmlink®RLSP5542025-05-16
00816312027730Rhythmlink®RLSP5552025-05-16
00816312027747Rhythmlink®RLSP5562025-05-16
10816312027652Rhythmlink®RLSND801-2.52025-05-05
10816312027669Rhythmlink®RLSND802-2.52025-05-05
10816312027690Rhythmlink®MRQDW106302025-04-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09342451003980Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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09342451004024Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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09342451004314Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004611Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004628Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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09342451004642Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004659Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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09342451004710Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004727Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004734Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004741Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004758Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02