Etrinsa 8 HF-T 394919

GUDID 04035479131777

BIOTRONIK SE & Co. KG

Cardiac resynchronization therapy implantable pacemaker

• Primary Device ID: 04035479131777
• NIH Device Record Key: 6461deb7-3767-4b9b-b5ba-dbbf7507fd1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etrinsa 8 HF-T
• Version Model Number: 394919
• Catalog Number: 394919
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479131777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950037

FDA Product Code

• NKE: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

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: 2021-02-05
• Device Publish Date: 2014-12-09

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• 04035479186005 - NEO: 2024-06-25
• 04035479186012 - PSW: 2024-06-25
• 04035479052515 - PK-222 US/2,8m: 2024-06-06
• 04035479186128 - Home Monitoring Service Center: 2024-06-06