Entovis SR-T 371994

GUDID 04035479115197

BIOTRONIK SE & Co. KG

Single-chamber implantable pacemaker, rate-responsive

• Primary Device ID: 04035479115197
• NIH Device Record Key: b0b637cd-74e7-47a2-af8c-ffce09c79b45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entovis SR-T
• Version Model Number: 371994
• Catalog Number: 371994
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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	04035479115197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950037

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: 2021-02-05
• Device Publish Date: 2014-08-19

On-Brand Devices [Entovis SR-T]

• 04035479115197: 371994
• 04035479109837: 365467