FDA.reportPublic FDA data

Heartsync by Vermed

Primary DI
50009336009669
Brand
Heartsync by Vermed
Company
GRAPHIC CONTROLS ACQUISITION CORP
Model
T100AC-ZOLL-10
Catalog number
6600096H
Device description
DEFIB ELECTRODE
Published
2019-10-17
Public version status
New
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
MKJAutomated External Defibrillators (Non-Wearable)
MLNElectrode, Electrocardiograph, Multi-Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3
MLNElectrode, Electrocardiograph, Multi-FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080421000HEART SYNC, MODELS C-100 AND T-100Heart Sync, LLC2008-02-29MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50009336009669PackageGS110In Commercial Distribution
00009336009664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5000933600966950009336009669
00009336009664000093360096640093360096640009336009664

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillator electrode padA conductive medium designed to be used between the metal contact surface of an external defibrillator electrode, of the paddle-type, and the patient's skin. A defibrillator electrode pad is available in two basic designs: 1) a thickened conductive gel or polymer layer reinforced by a non-woven material; or 2) a conductive adhesive pad with a metal contact on its outer surface. 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002111896
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
30009336010630Nissha Medical TechnologiesUltra 210HD Thermal Video Paper320190642026-06-01
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
00815098021475Defibtech ARM XR Extended Suction Cup (package of 1)DEFIBTECH, L.L.C.MKJ2026-06-26
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
00883873031902LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031933LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031957LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031971LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031995LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873032015LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873032145LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00197644380145AED Battery ExchangeAED BATTERY EXCHANGE, LLCMKJ2026-04-15
10847946001435PEDI PADZZoll Medical CorporationMKJ2026-02-12
10847946016231ONESTEPZoll Medical CorporationMKJ2026-02-12
10847946023345ONESTEPZoll Medical CorporationMKJ2026-02-12
07613327673197LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673227LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673234LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673241LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673258LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673265LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673357LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327681864LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
00883873760482BATTERY, LI-ION, WITH IFU, LP35PHYSIO-CONTROL, INC.MKJ2025-09-26
00883873761533LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761540LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761557LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761564LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761571LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761588LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761595LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04