Fortify™ CD2231-40

GUDID 05414734504379

Tiered-therapy cardioverter/defibrillator VVED DDDR

ST. JUDE MEDICAL, INC.

Dual-chamber implantable defibrillator

• Primary Device ID: 05414734504379
• NIH Device Record Key: f3417e84-35da-4108-8832-7fe42d16d9d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortify™
• Version Model Number: DR
• Catalog Number: CD2231-40
• Company DUNS: 790268031
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734504379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P910023

FDA Product Code

• NVZ: Pulse generator, permanent, implantable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-27
• Device Publish Date: 2017-02-03

On-Brand Devices [Fortify™]

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