Remote Assistant 435292

GUDID 04035479158330

BIOTRONIK SE & Co. KG

Implantable cardiac monitor programmer/transmitter/alarm

• Primary Device ID: 04035479158330
• NIH Device Record Key: 1e74199c-1dde-483c-ab2d-80cd66094cea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remote Assistant
• Version Model Number: III
• Catalog Number: 435292
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479158330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190548

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-09
• Device Publish Date: 2019-07-10

Devices Manufactured by BIOTRONIK SE & Co. KG

• 04035479184575 - BIOTRONIK: 2024-02-28
• 04035479116644 - Selectra: 2024-01-25
• 04035479184285 - NEO: 2023-12-25
• 04035479184292 - PSW: 2023-12-25
• 04035479185510 - Renamic Neo NEOexpress: 2023-12-25
• 04035479183264 - Home Monitoring Service Center: 2023-10-23
• 04035479100650 - S 60-C: 2023-10-09
• 04035479011864 - S 75-A: 2023-10-06