Itrevia 5 DR-T 392422

GUDID 04035479128906

BIOTRONIK SE & Co. KG

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 Dual-chamber implantable defibrillator

• Primary Device ID: 04035479128906
• NIH Device Record Key: f8f787dc-8762-407b-88b7-e6ca9a6e1c7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Itrevia 5 DR-T
• Version Model Number: 392422
• Catalog Number: 392422
• Company DUNS: 315620229
• Company Name: BIOTRONIK SE & Co. KG
• 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: false
• 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(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479128906 [Primary]

FDA Product Code

• MRM: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

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: 2019-10-28
• Device Publish Date: 2015-02-18

On-Brand Devices [Itrevia 5 DR-T]

• 04035479128906: 392422
• 04035479128852: 392417