FDA.reportPublic FDA data

Med-Dyne

Primary DI
00817497020561
Brand
Med-Dyne
Company
MED-DYNE, INC.
Model
G24AS
Device description
"PRE-WIRED ELECTRODE 24"" LONG LEAD WIRE - SET OF 3"
Published
2016-09-24
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
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080112000PATIENT CABLEMed-Dyne2008-06-20DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817497020561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817497020561008174970205618174970205610817497020561

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, single-useA collection of non-sterile, noninvasive devices intended to be used 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 includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length24Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
826176703
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817497020667Med-DyneGBK60-122016-09-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719689142209QMAPP Fysicon B.V.DSA2026-05-19
08719689142216QMAPP Fysicon B.V.DSA2026-05-19
08719689142223QMAPP Fysicon B.V.DSA2026-05-19
08719689142247QMAPP Fysicon B.V.DSA2026-05-19
08719689142254QMAPP Fysicon B.V.DSA2026-05-19
08719689142261QMAPP Fysicon B.V.DSA2026-05-19
08719689142322QMAPPFysicon B.V.DSA2026-05-19
08719689142339QMAPPFysicon B.V.DSA2026-05-19
08719689142346QMAPPFysicon B.V.DSA2026-05-19
08719689142353QMAPPFysicon B.V.DSA2026-05-19
08719689142360QMAPPFysicon B.V.DSA2026-05-19
08719689142377QMAPPFysicon B.V.DSA2026-05-19
08719689142384QMAPPFysicon B.V.DSA2026-05-19
08719689142391QMAPPFysicon B.V.DSA2026-05-19
08719689142407QMAPPFysicon B.V.DSA2026-05-19
08719689142414QMAPPFysicon B.V.DSA2026-05-19
08719689142469QMAPPFysicon B.V.DSA2026-05-19
08719689142476QMAPPFysicon B.V.DSA2026-05-19
08719689142483QMAPPFysicon B.V.DSA2026-05-19
08719689142490QMAPPFysicon B.V.DSA2026-05-19
08719689142506QMAPPFysicon B.V.DSA2026-05-19
08719689142513QMAPPFysicon B.V.DSA2026-05-19
08719689142520QMAPPFysicon B.V.DSA2026-05-19
08719689142537QMAPPFysicon B.V.DSA2026-05-19
08719689142544QMAPPFysicon B.V.DSA2026-05-19
08719689142551QMAPPFysicon B.V.DSA2026-05-19
08719689142568QMAPPFysicon B.V.DSA2026-05-19
08719689142575QMAPPFysicon B.V.DSA2026-05-19
08719689142582QMAPPFysicon B.V.DSA2026-05-19
08719689142599QMAPP Fysicon B.V.DSA2026-05-19