LUX-Dx™ Clinic Assistant app 622935-100

GUDID 00802526607615

LUX-Dx Clinic Assistant app (Mobile application)

BOSTON SCIENTIFIC CORPORATION

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• Primary Device ID: 00802526607615
• NIH Device Record Key: 162aff39-db50-420d-a0e9-3b610f57c882
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUX-Dx™ Clinic Assistant app
• Version Model Number: 622935-100
• Catalog Number: 622935-100
• 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	00802526607615 [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

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• 08714729042570 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042587 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042594 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042600 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729154921 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729154969 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729191872 - Passport: 2024-04-05 Balloon Dilatation Catheter