LUX-Dx™ 667256-110

GUDID 00802526625404

For use with Insertable Cardiac Monitor system

BOSTON SCIENTIFIC CORPORATION

Implantable cardiac device management application software

• Primary Device ID: 00802526625404
• NIH Device Record Key: 55aadc0d-72bf-4d2b-b930-b8ed038a005d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUX-Dx™
• Version Model Number: 667256-110
• Catalog Number: 667256-110
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	00802526625404 [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: 2024-10-08
• Device Publish Date: 2024-09-30

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