Pamira 428773

GUDID 04035479156497

BIOTRONIK SE & Co. KG

Endocardial defibrillation lead

• Primary Device ID: 04035479156497
• NIH Device Record Key: e717c6d1-5638-4dac-b141-26ae78deeb8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pamira
• Version Model Number: SD 65/18
• Catalog Number: 428773
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479156497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980023

FDA Product Code

• NVY: Permanent defibrillator electrodes

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: 2023-09-08
• Device Publish Date: 2023-01-24

On-Brand Devices [Pamira]

• 04035479156527: S DX 65/17
• 04035479156510: S DX 65/15
• 04035479156503: SD 75/18
• 04035479156497: SD 65/18
• 04035479156480: SD 65/16
• 04035479156473: SD 60/16
• 04035479156466: S 75
• 04035479156459: S 65
• 04035479156442: S 60