Heartsync by Vermed 6600063H

GUDID 50009336009614

Defibrillator Electrodes

GRAPHIC CONTROLS ACQUISITION CORP

External defibrillator electrode pad
Primary Device ID50009336009614
NIH Device Record Keybebcd7ae-1a96-45b6-9b1d-e464330830cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartsync by Vermed
Version Model NumberPED-100
Catalog Number6600063H
Company DUNS002111896
Company NameGRAPHIC CONTROLS ACQUISITION CORP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com
Phone800-669-6905
Emailinfo@vermed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100009336009619 [Primary]
GS150009336009614 [Package]
Contains: 00009336009619
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDDDc-Defibrillator, Low-Energy, (Including Paddles)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-25
Device Publish Date2019-10-17

On-Brand Devices [Heartsync by Vermed]

50009336009683Debrillator electrode
50009336009676Defibrillation electrode
50009336009669DEFIB ELECTRODE
50009336009645Defib Electrode
50009336009638DEFIB ELECTRODE
50009336009621Defib Electrode
50009336009614Defibrillator Electrodes
50009336009607DEFIB ELECTRODE
50009336009591DEFIB ELECTRODE
50009336009584DEFIB
50009336009577DEFIB ELECTRODE
50009336009560DEFIB ELECTRODE
50009336009553DEFIB ELECTRODE
50009336009546DEFIB ELECTRODE
50009336009539DEFIB ELECTRODE
50009336009522Defibrillation electrode
50009336009515Defibrillation electrode
50009336009508DEFIB ELECTRODES
50009336009492Defib Electrode
50009336009485DEFIB ELECTRODE
50009336009478Defibrillator Electrode
50009336010092Defib Electrode
50009336010085DEFIB ELECTRODE

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