myLUX™ Patient App 622929-120

GUDID 00802526623110

For Insertable Cardiac Monitor

BOSTON SCIENTIFIC CORPORATION

Implantable cardiac device management application software

• Primary Device ID: 00802526623110
• NIH Device Record Key: 79577c1b-2342-41a5-bc47-b40cde7fe116
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myLUX™ Patient App
• Version Model Number: 622929-120
• Catalog Number: 622929-120
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526623110 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-08
• Device Publish Date: 2023-08-31

On-Brand Devices [myLUX™ Patient App]

• 00802526607608: myLUX patient app (mobile application)
• 00802526623110: For Insertable Cardiac Monitor
• 00802526623103: for Insertable Cardiac Monitor