CELERITY 383390

GUDID 04035479143251

BIOTRONIK SE & Co. KG

Coronary venous pacing lead

• Primary Device ID: 04035479143251
• NIH Device Record Key: de42b4c8-41c9-46a1-ab85-3130490dbfc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CELERITY
• Version Model Number: 2D 75
• Catalog Number: 383390
• 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: 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

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479143251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P070008

FDA Product Code

• OJX: Drug eluting permanent left ventricular (lv) pacemaker electrode

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 [CELERITY]

• 04035479143282: Pilot 75
• 04035479143275: Pilot 85
• 04035479143268: 2D 85
• 04035479143251: 2D 75
• 04035479143244: 3D 75
• 04035479143237: 3D 85