LUX-Dx II+™ 60M312-100

GUDID 00802526620706

Insertable Cardiac Monitor

BOSTON SCIENTIFIC CORPORATION

Implantable cardiac monitor

• Primary Device ID: 00802526620706
• NIH Device Record Key: 8d14ecb0-a0a7-4542-b1b5-d4a719f826fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUX-Dx II+™
• Version Model Number: 60M312-100
• Catalog Number: 60M312-100
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526620706 [Primary]

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

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• 08714729339830 - Percuflex™: 2026-02-17 Ureteral Stent Set
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• 08714729424222 - Contour™: 2026-02-17 Ureteral Stent Set