BioMonitor 394119

GUDID 04035479131210

BIOTRONIK SE & Co. KG

Implantable cardiac monitor

• Primary Device ID: 04035479131210
• NIH Device Record Key: 73214ec7-a561-4981-8c70-570542f126b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioMonitor
• Version Model Number: 394119
• Catalog Number: 394119
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479131210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143503

FDA Product Code

• MXD: RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-09
• Device Publish Date: 2015-03-30

On-Brand Devices [BioMonitor]

• 04035479158453: III
• 04035479135539: 2-S
• 04035479135522: 2-AF
• 04035479131210: 394119
• 04035479144227: Remote Assistant
• 04035479169862: IIIm
• 04035479149314: FIT-Fast Insert Tool 1 + 2, Set