LUX-Dx™ Insertable Cardiac Monitor 60M301-101

GUDID 00802526607103

LUX-Dx Insertable Cardiac Monitor

BOSTON SCIENTIFIC CORPORATION

Implantable cardiac monitor

• Primary Device ID: 00802526607103
• NIH Device Record Key: d424f4c6-1c56-440a-b773-4f18d6798912
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUX-Dx™ Insertable Cardiac Monitor
• Version Model Number: M301
• Catalog Number: 60M301-101
• 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: true
• 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	00802526607103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193473

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: 2020-07-09
• Device Publish Date: 2020-07-01

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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• 00191506043964 - FARASTAR™: 2026-01-28 EGM to EP Recording System Cable (FARAPOINT™)
• 00191506047207 - FARAPOINT™: 2026-01-28 Pulsed Field Ablation Catheter
• 00191506047221 - FARAPOINT™: 2026-01-28 Pulsed Field Ablation Catheter
• 00191506055073 - FARASTAR™: 2026-01-28 Inter-Connection Box
• 00191506057688 - FARASTAR™: 2026-01-28 Pulsed Field Ablation Generator
• 08714729780489 - Blazer™ Dx-20: 2026-01-21 Bidirectional Steerable Diagnostic Catheter
• 08714729780496 - Blazer™ Dx-20: 2026-01-21 Bidirectional Steerable Diagnostic Catheter