FDA.reportPublic FDA data

Med-Dyne

Primary DI
00817497021469
Brand
Med-Dyne
Company
MED-DYNE, INC.
Model
REL1000-100
Device description
REUSABLE BLACK CARBON ELECTRODES - PACK OF 100 (SINGLE PATIENT USE)
Published
2016-09-26
Public version status
Update
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
00817497021469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817497021469008174970214698174970214690817497021469

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal physiologic monitoring systemA device assembly designed to continuously measure and display multiple vital physiological parameters of newborn and premature infants, especially those under critical care. It is typically capable of monitoring parameters such as electrocardiogram (ECG), respiration rate, heart rate, blood pressure, and body temperature; it may also assess haemoglobin oxygen saturation (SpO2) through transcutaneous sensors that measure both transcutaneous oxygen (tcPO2) and transcutaneous carbon dioxide (tcPCO2) saturation. The system typically includes sensors with appropriate size and design for infant use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
502-429-4140SALES@MED-DYNE.COM

Regulatory Flags#

DUNS number
826176703
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
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
10817497020667Med-DyneGBK60-122016-09-26
00868795000205Med-DyneSCL8000SCL80002016-09-26
00868795000212Med-DyneSCL9000SCL90002016-09-26
00868795000229Med-DyneDEL3000DEL30002016-09-24
00868795000236Med-DyneDEL3000ADEL3000A2016-09-24
00868795000243Med-DyneDEL3000I2016-09-24
00868795000250Med-DyneDELF3000L2016-09-24
00817497020530Med-DyneG24AL2016-09-24
00817497020547Med-DyneG24AR2016-09-24
00817497020554Med-DyneG24AR-302016-09-24
00817497020561Med-DyneG24AS2016-09-24
00817497020578Med-DyneG24BS2016-09-24
00817497020585Med-DyneG4830-302016-09-24
00817497020592Med-DyneG48AS2016-09-24
00817497020608Med-DyneG536L2016-09-24
00817497020615Med-DyneG536S2016-09-24
00817497020622Med-DyneG60AS2016-09-24
00817497020844Med-DyneGE84-402016-09-24
00817497020851Med-DyneGE84-602016-09-24
00817497020998Med-DyneGL4024-402016-09-24

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
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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
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06946725512807APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512814APKAPK Technology Co.,Ltd.DRX2026-01-23
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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