FDA.reportPublic FDA data

Heartsync by Vermed

Primary DI
00009336009541
Brand
Heartsync by Vermed
Company
GRAPHIC CONTROLS ACQUISITION CORP
Model
T100AC-PHYSIO
Catalog number
6600093H
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
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50009336009546PackageGS110In Commercial Distribution
00009336009541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5000933600954650009336009546
00009336009541000093360095410093360095410009336009541

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillation electrode, adult, single-useAn electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with self-affixing pads (the electrodes) designed to be applied to the chest or back of the patient so that the discharge passes across the region of the heart. It may also be used for electrocardiographic analysis prior to shock delivery. The device may remain applied to the patient during stages of treatment. 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
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
00810149098291R&D Batteries, Inc.R & D Batteries, Inc.MKJ2026-04-01
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
00810149098208R&D Batteries, Inc.R & D Batteries, Inc.MKJ2025-11-19
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