myLUX™ patient app 622925-100

GUDID 00802526607608

myLUX patient app (mobile application)

BOSTON SCIENTIFIC CORPORATION

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• Primary Device ID: 00802526607608
• NIH Device Record Key: c014df38-fffa-46d4-a2a3-e58656a117ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myLUX™ patient app
• Version Model Number: 622925-100
• Catalog Number: 622925-100
• 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: 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	00802526607608 [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

On-Brand Devices [myLUX™ patient app]

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