FDA.reportPublic FDA data

Heartsync by Vermed

Primary DI
00009336009497
Brand
Heartsync by Vermed
Company
GRAPHIC CONTROLS ACQUISITION CORP
Model
T100AC
Catalog number
6600090H
Device description
Defib Electrode
Published
2019-10-17
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
MLNElectrode, Electrocardiograph, Multi-Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLNElectrode, Electrocardiograph, Multi-FunctionCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50009336009492PackageGS110In Commercial Distribution
00009336009497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5000933600949250009336009492
00009336009497000093360094970093360094970009336009497

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive skin pad, single-useA noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
800-669-6905info@vermed.com

Regulatory Flags#

DUNS number
002111896
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30009336010630Nissha Medical TechnologiesUltra 210HD Thermal Video Paper320190642026-06-01
00009336008216Vermed20100-125-SNAP20100-125-SNAP2017-02-28
00009336008223Vermed20300-18-RED20300-18-RED2017-02-28
00009336008230Vermed20300-18-WHT20300-18-WHT2017-02-28
00009336008247Vermed20900-18-3A20900-18-3A2017-02-28
00009336008254Vermed20900-24-3A20900-24-3A2018-09-28
00009336008261Vermed20900-53-GRN20900-53-GRN2017-02-28
00009336008278Vermed20900-96-RED20900-96-RED2017-02-28
00009336008315Vermed41656416562017-02-28
00009336008322Vermed20900-18-RED20900-18-RED2017-02-28
00009336008339Vermed20900-48-WHT20900-48-WHT2017-02-28
10009336010322Zoll PL Defib8900-004041-017000018322023-10-30
10813150020227PerformancePlus™A10005A100052016-09-16
50813150020911NeuroPlus™A10041-5A10041-52017-04-07
00813150020107PerformancePlus™A10005-4NBA10005-4NB2016-09-16
00813150020121PerformancePlus™A10005-60A10005-602016-09-16
00813150020183PerformancePlus™A10005-7NBA10005-7NB2016-09-16
20813150020941NeuroPlus™A10042-10A10042-102017-04-07
20813150020972NeuroPlus™A10043A100432017-04-07
40813150020860NeuroPlus™A10040-5A10041-02017-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00009336010080Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
00009336010097Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
50009336010085Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
50009336010092Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
10888277634893MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634909MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634961MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634985MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634992MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635005MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635012MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635029MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635036MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635050MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635067MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635074MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635081MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635098MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635104MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
00326053105456Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105463Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105470Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105555Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
10326053105453Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105460Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105477Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105552Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
00009336009503Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17
00009336009510Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17
00009336009527Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17