Ilivia 7 HF-T QP 404621

GUDID 04035479142087

BIOTRONIK SE & Co. KG

Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator

• Primary Device ID: 04035479142087
• NIH Device Record Key: 2dfca177-3e0c-49a1-83e8-d7ae3c9af6fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ilivia 7 HF-T QP
• Version Model Number: 404621
• Catalog Number: 404621
• Company DUNS: 315620229
• Company Name: BIOTRONIK SE & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479142087 [Primary]

FDA Product Code

• NIK: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

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: 2017-05-18

Devices Manufactured by BIOTRONIK SE & Co. KG

• 04035479184575 - BIOTRONIK: 2024-02-28
• 04035479116644 - Selectra: 2024-01-25
• 04035479184285 - NEO: 2023-12-25
• 04035479184292 - PSW: 2023-12-25
• 04035479185510 - Renamic Neo NEOexpress: 2023-12-25
• 04035479183264 - Home Monitoring Service Center: 2023-10-23
• 04035479100650 - S 60-C: 2023-10-09
• 04035479011864 - S 75-A: 2023-10-06