Current® 1107-36

GUDID 05414734502184

Tiered-therapy cardioverter/defibrillator VVEV VVIR

ST. JUDE MEDICAL, INC.

Single-chamber implantable defibrillator

• Primary Device ID: 05414734502184
• NIH Device Record Key: 62b4b618-6dbd-4993-bb9d-06aaf9def119
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Current®
• Version Model Number: VR
• Catalog Number: 1107-36
• 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

Device Dimensions

• Total Volume: 38 Milliliter
• Total Volume: 38 Milliliter
• Total Volume: 38 Milliliter
• Total Volume: 38 Milliliter
• Total Volume: 38 Milliliter
• Total Volume: 38 Milliliter
• Total Volume: 38 Milliliter
• Total Volume: 38 Milliliter
• Total Volume: 38 Milliliter
• Total Volume: 38 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 away from magnets and sources of electromagnetic interference.
• 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 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 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734502184 [Primary]
HIBCC	H7581107360 [Secondary]

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: 4
• Public Version Date: 2020-05-04
• Device Publish Date: 2017-01-24

On-Brand Devices [Current®]

• 05414734502207: Tiered-therapy cardioverter/defibrillator VVED DDDR
• H75821073005: Tiered-therapy cardioverter/defibrillator VVED DDDR
• 05414734502184: Tiered-therapy cardioverter/defibrillator VVEV VVIR
• 05414734501941: Tiered-therapy cardioverter/defibrillator VVEV VVIR
• H75812073005: Tiered-therapy cardioverter/defibrillator VVEV VVIR
• 05414734501927: Tiered-therapy cardioverter/defibrillator VVED DDDR
• H75822073006: Tiered-therapy cardioverter/defibrillator VVED DDDR