myLUX™ Patient Kit with mobile device 666259-100

GUDID 00802526607363

MyLUX(TM) Patient Kit with mobile device

BOSTON SCIENTIFIC CORPORATION

Implantable cardiac device management application software

• Primary Device ID: 00802526607363
• NIH Device Record Key: 228d4525-8848-4eba-9b40-d5f9ee900a3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myLUX™ Patient Kit with mobile device
• Version Model Number: 666259-100
• Catalog Number: 666259-100
• 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	00802526607363 [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: false

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

• 08714729269915 - Electrophysiology Cable: 2025-01-15 Sterile Cable
• 08714729877868 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877875 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877882 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877899 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877905 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877912 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877929 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter