Acticor 7 DR-T 429524

GUDID 04035479156695

BIOTRONIK SE & Co. KG

Dual-chamber implantable defibrillator

• Primary Device ID: 04035479156695
• NIH Device Record Key: 174e44af-2310-48f5-87a5-2d001d250e8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acticor 7 DR-T
• Version Model Number: 429524
• Catalog Number: 429524
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479156695 [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: 2
• Public Version Date: 2019-10-28
• Device Publish Date: 2019-03-18

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• 04035479184636 - Home Monitoring Service Center: 2024-09-23
• 04035479187163 - Home Monitoring Service Center: 2024-09-11
• 04035479186005 - NEO: 2024-06-25
• 04035479186012 - PSW: 2024-06-25
• 04035479052515 - PK-222 US/2,8m: 2024-06-06