Allure Quadra™ PM3242

GUDID 05414734507912

Cardiac Resynchronization Therapy Device, Pulse Generator DDDRV

ST. JUDE MEDICAL, INC.

Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker
Primary Device ID05414734507912
NIH Device Record Keyf763f154-df75-4cc0-8b06-052b79649baa
Commercial Distribution StatusIn Commercial Distribution
Brand NameAllure Quadra™
Version Model NumberRF
Catalog NumberPM3242
Company DUNS790268031
Company NameST. JUDE MEDICAL, INC.
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter
Total Volume15 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734507912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-04-10

On-Brand Devices [Allure Quadra™]

05414734507912Cardiac Resynchronization Therapy Device, Pulse Generator DDDRV
05414734507899Cardiac Resynchronization Therapy Device, Pulse Generator DDDRV 

Trademark Results [Allure Quadra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALLURE QUADRA
ALLURE QUADRA
85740714 4452357 Live/Registered
Pacesetter, Inc.
2012-09-27

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