LUX-Dx™ Clinic Assistant Kit with mobile device 666256-100

GUDID 00802526607370

LUX-Dx(TM) Clinic Assistant Kit with mobile device

BOSTON SCIENTIFIC CORPORATION

Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software

• Primary Device ID: 00802526607370
• NIH Device Record Key: 0cc4baeb-895b-405e-bd22-72d8d38380b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUX-Dx™ Clinic Assistant Kit with mobile device
• Version Model Number: 666256-100
• Catalog Number: 666256-100
• 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	00802526607370 [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

• 08714729042549 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 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