FDA.reportPublic FDA data

Medline

Primary DI
80888277181426
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDSM619350R
Catalog number
MDSM619350R
Device description
ELECTRODE,FOAM,WET GEL, RADIOTRANS,50/PK
Published
2020-12-24
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80888277181426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8088827718142680888277181426

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive 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
Special Storage Condition, Specify00Keep away from sunlight Protect from Freezing, avoid excessive heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009331808EXG Radiolucent Electrode System 12-Lead ElectrodeCB Innovations, LLCDRX2026-03-09
10860009331812EXG Radiolucent Electrode System 3-Lead Posterior ElectrodeCB Innovations, LLCDRX2026-03-09
10860009331898EXG Radiolucent Electrode System 4-Lead ElectrodeCB Innovations, LLCDRX2026-03-09
00860009331853EXG Radiolucent Electrode 5-Lead Cardiac Rhythm ElectrodeCB Innovations, LLCDRX2026-03-05
30009336010593Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPDRX2026-02-26
30009336010609Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPDRX2026-02-26
08033315120394BIONENBIONEN SAS DI BARBARA NENCIONI & C.DRX2026-02-16
06946725512708APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512715APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512722APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512739APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512746APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512753APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512760APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512777APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512784APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512791APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512807APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512814APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512821APKAPK Technology Co.,Ltd.DRX2026-01-23
00853512006998NIKOTRACENIKOMED USADRX2026-01-23
06946725512685APKAPK Technology Co.,Ltd.DRX2026-01-20
06946725512692APKAPK Technology Co.,Ltd.DRX2026-01-20
29005531002764SkintactLeonhard Lang GmbHDRX2026-01-15
29005531003044SkintactLeonhard Lang GmbHDRX2026-01-14
04719872981640QT ECGQt Medical, Inc.DRX2025-12-30
06946725512364APKAPK Technology Co.,Ltd.DRX2025-12-25
06946725512371APKAPK Technology Co.,Ltd.DRX2025-12-25
06946725512388APKAPK Technology Co.,Ltd.DRX2025-12-25
06946725512395APKAPK Technology Co.,Ltd.DRX2025-12-25