Fortify Assura™ CD2357-40QC

GUDID 05414734508087

Tiered-therapy cardioverter/defibrillator VVED DDDR

ST. JUDE MEDICAL, INC.

Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator
Primary Device ID05414734508087
NIH Device Record Key7eb78186-f981-40ec-b579-b17971dd4573
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortify Assura™
Version Model NumberDR
Catalog NumberCD2357-40QC
Company DUNS790268031
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Dimensions

Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter
Total Volume35 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734508087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVZPulse generator, permanent, implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-27
Device Publish Date2017-02-03

On-Brand Devices [Fortify Assura™]

05414734508094Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734508087Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734508070Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734508063Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734507974Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734507967Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734507950Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734507943Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734505550Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734505543Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734505475Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734505468Tiered-therapy cardioverter/defibrillator VVEV VVIR

Trademark Results [Fortify Assura]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FORTIFY ASSURA
FORTIFY ASSURA
85392023 4199898 Live/Registered
Pacesetter, Inc.
2011-08-08

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