FDA.reportPublic FDA data

Med-Dyne

Primary DI
10817497020667
Brand
Med-Dyne
Company
MED-DYNE, INC.
Model
GBK60-12
Device description
"60"" GOLD CUP ELECTRODE - BLACK LEAD WIRE - SET OF 12"
Published
2016-09-26
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
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817497020667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081749702066710817497020667

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, single-useA collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
502-429-4140sales@med-dyne.com

Regulatory Flags#

DUNS number
826176703
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817497020813Med-DyneGDBK482016-09-24
00868795000205Med-DyneSCL8000SCL80002016-09-26
00868795000212Med-DyneSCL9000SCL90002016-09-26
00817497020004Med-Dyne204BKBK01A22016-09-26
00817497020011Med-Dyne204WHWH01A204WHWH01A2016-09-26
00817497020042Med-Dyne381-0032016-09-26
00817497020059Med-Dyne381-0042016-09-26
00817497020066Med-Dyne381-0062016-09-26
00817497020073Med-Dyne381-0092016-09-26
00817497020080Med-Dyne381-0202016-09-26
00817497020097Med-Dyne630-0052016-09-26
00817497020103Med-Dyne630-0062016-09-26
00817497020110Med-Dyne630-0072016-09-26
00817497020127Med-Dyne630-0112016-09-26
00817497020134Med-Dyne630-011-182016-09-26
00817497020141Med-Dyne630-011-602016-09-26
00817497020158Med-Dyne630-011S2016-09-26
00817497020165Med-Dyne630-011S-602016-09-26
00817497020172Med-Dyne630-0122016-09-26
00817497020189Med-Dyne630-012-182016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572931APKAPK Technology Co.,Ltd.IKD2026-10-26
06946725502341APKAPK Technology Co.,Ltd.IKD2026-10-22
06946725500989APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500996APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501009APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501016APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501030APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501047APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501054APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501061APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501078APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501085APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501092APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501108APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501115APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501122APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501139APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501146APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501153APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501160APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501177APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501184APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501191APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501207APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501214APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501221APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501238APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501245APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501252APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501269APKAPK Technology Co.,Ltd.IKD2025-07-22