FDA.reportPublic FDA data

Rhythmlink®

Primary DI
00816312025880
Brand
Rhythmlink®
Company
RHYTHMLINK INTERNATIONAL, LLC
Model
RLITD2910
Device description
Kit of 25 Deep Cup Electrodes and 4 Recording Sticky Pad Electrodes
Published
2021-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00816312025880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816312025880008163120258808163120258800816312025880

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous electrodeA non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8666333754xx@xx.xx

Regulatory Flags#

DUNS number
126290993
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816312028065Rhythmlink®MRQWS423152026-05-18
10816312028048Rhythmlink®MRDC25152026-03-30
10816312027966Rhythmlink®DC31152026-02-13
00816312027969Rhythmlink®DC31152026-02-13
10816312027959Rhythmlink®DC2415202026-01-12
00816312027945Rhythmlink®MRQWD3040405152026-01-12
00816312025910Rhythmlink®SP2100012021-08-06
00816312027921Rhythmlink®MRQD31006101522025-12-08
00816312027853Rhythmlink®CTGN2121-2.52025-12-05
10816312027850Rhythmlink®CTGN2121-2.52025-12-05
00816312027860Rhythmlink®CTGN2121-2.52025-12-03
10816312027867Rhythmlink®CTGN2121-2.52025-12-03
00816312027907Rhythmlink®DCDECUL3315202025-11-21
00816312027914Rhythmlink®SCDECUS2610152025-11-21
10816312027898Rhythmlink®DC29152025-11-07
10816312023104Rhythmlink®RLSP5222020-06-02
00816312025163Rhythmlink®RLSP531C2022-09-21
00816312027020Rhythmlink®MRQD3291532023-10-24
00816312026979Rhythmlink®MRQD3231522023-09-05
00816312026832Rhythmlink®MRQD3241522023-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B195XC813waveguardeemagine Medical Imaging Solutions GmbHGXY2026-03-19
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00860008546005Nexalin ADINEXALIN TECHNOLOGYGXY2026-03-16
09342451004772Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-03
00850080988121AUVONUAN HEALTHCARE LIMITEDGXY2026-03-02
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09342451003980Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451003997Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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09342451004024Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004031Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004314Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004611Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004628Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004635Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004642Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004659Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004673Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004680Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004697Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004703Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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