Fortify™ CD1231-40

GUDID 05414734504355

Tiered-therapy cardioverter/defibrillator VVEV VVIR

ST. JUDE MEDICAL, INC.

Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator
Primary Device ID05414734504355
NIH Device Record Key87e84097-3cff-41b7-b3d2-2d37ca606f1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortify™
Version Model NumberVR
Catalog NumberCD1231-40
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

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

Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device away from magnets and sources of electromagnetic interference.
Storage Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 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
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
GS105414734504355 [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™]

05414734504386Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734504379Tiered-therapy cardioverter/defibrillator VVED DDDR
05414734504355Tiered-therapy cardioverter/defibrillator VVEV VVIR
05414734504348Tiered-therapy cardioverter/defibrillator VVEV VVIR

Trademark Results [Fortify]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FORTIFY
FORTIFY
97844389 not registered Live/Pending
Nouri Life, LLC
2023-03-17
FORTIFY
FORTIFY
97796648 not registered Live/Pending
Soma Products LLC
2023-02-15
FORTIFY
FORTIFY
97607648 not registered Live/Pending
Orchid Orthopedic Solutions, LLC
2022-09-26
FORTIFY
FORTIFY
97590501 not registered Live/Pending
Ark Naturals Company
2022-09-14
FORTIFY
FORTIFY
97480131 not registered Live/Pending
NewEraSOS, Inc.
2022-06-28
FORTIFY
FORTIFY
90836515 not registered Live/Pending
ROB-SEE-CO, LLC
2021-07-19
FORTIFY
FORTIFY
90640252 not registered Live/Pending
Colgate-Palmolive Company
2021-04-12
FORTIFY
FORTIFY
90489380 not registered Live/Pending
Sanara MedTech Inc.
2021-01-26
FORTIFY
FORTIFY
90480060 not registered Live/Pending
Aloha Exports LLC
2021-01-21
FORTIFY
FORTIFY
88788672 not registered Live/Pending
Elite Endeavors, LLC
2020-02-07
FORTIFY
FORTIFY
88769122 not registered Live/Pending
CVB INC
2020-01-22
FORTIFY
FORTIFY
88769092 not registered Live/Pending
CVB INC
2020-01-22

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