FDA.reportPublic FDA data

Rhythmlink®

Primary DI
00816312022681
Brand
Rhythmlink®
Company
RHYTHMLINK INTERNATIONAL, LLC
Model
STDTL
Device description
EEG Electrode Template
Published
2019-09-03
Public version status
New
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
00816312022681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816312022681008163120226818163120226810816312022681

GMDN Terms#

Term, Definition table
TermDefinition
Electrode/transducer strap, single-useA strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8666333754xx@xx.xx

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816312028638Rhythmlink®RLSP5602026-10-09
00816312028652Rhythmlink®RLSP5622026-10-09
00816312028669Rhythmlink®RLSP5632026-10-09
00816312028614Rhythmlink®RLSP5582026-10-08
00816312028621Rhythmlink®RLSP5592026-10-08
10816312028673Rhythmlink®RLSP5642026-09-21
00816312027822Rhythmlink®MRQD207071522026-06-10
00816312028072Rhythmlink®MRQW20908152026-06-01
00816312024401RHYTHMLINK INTERNATIONAL, LLCRLSP5332022-01-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851913006296UltraStim Wire FoamAXELGAARD MANUFACTURING CO., LTD.GXY2026-10-21
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731112Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16