Ellipse™ CD1311-36

GUDID 05414734506106

Tiered-therapy cardioverter/defibrillator VVEV VVIR

ST. JUDE MEDICAL, INC.

Single-chamber implantable defibrillator

• Primary Device ID: 05414734506106
• NIH Device Record Key: dd3b0005-b028-409d-ac66-595c2e535264
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ellipse™
• Version Model Number: VR
• Catalog Number: CD1311-36
• 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter
• Total Volume: 30.6 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734506106 [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: 2017-02-02

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• 05414734507608: Tiered-therapy cardioverter/defibrillator VVED DDDR
• 05414734507592: Tiered-therapy cardioverter/defibrillator VVED DDDR
• 05414734507585: Tiered-therapy cardioverter/defibrillator VVED DDDR
• 05414734506113: Tiered-therapy cardioverter/defibrillator VVEV VVIR
• 05414734506106: Tiered-therapy cardioverter/defibrillator VVEV VVIR
• 05414734506038: Tiered-therapy cardioverter/defibrillator VVEV VVIR
• 05414734506021: Tiered-therapy cardioverter/defibrillator VVEV VVIR
• 05414734505994: Tiered-therapy cardioverter/defibrillator VVED DDDR
• 05414734505987: Tiered-therapy cardioverter/defibrillator VVED DDDR
• 05414734505918: Tiered-therapy cardioverter/defibrillator VVED DDDR
• 05414734505901: Tiered-therapy cardioverter/defibrillator VVED DDDR