FDA.reportPublic FDA data

Med-Dyne

Primary DI
00817497022992
Brand
Med-Dyne
Company
MED-DYNE, INC.
Model
GE84
Device description
"PRE-WIRED HYDRO GEL ELECTRODE - 24"" LONG - SET OF 4 (2 BLACK / 2 WHITE)"
Published
2016-10-04
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
00817497022992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817497022992008174970229928174970229920817497022992

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. 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

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Primary DI, Brand, Company table
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00840416607161FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607178FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607185FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
08720938410383Cardiac, 10-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410390Cardiac, 10-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410406IR, 5-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410413IR, 5-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410420ACIST FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410437Volcano (Philips) FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410444ABBOTT FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410451BOSTON FFR Connection KitFysicon B.V.DSA2026-08-14
00840416607079FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607086FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607093FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607109FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
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G662ME590280T11MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280Y1MaguireMaguire Enterprises, Inc.DSA2026-07-28
03700506300853INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-07-24