LATITUDE®

GUDID 00802526562112

Patient Management System

BOSTON SCIENTIFIC CORPORATION

Patient health record information system application software

• Primary Device ID: 00802526562112
• NIH Device Record Key: 0a76d8bc-53b7-4318-8c64-446b959e6951
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LATITUDE®
• Version Model Number: 6488
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00802526562112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P910077

FDA Product Code

• LWS: Implantable cardioverter defibrillator (non-CRT)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [LATITUDE®]

• 00802526579226: Patient Management System
• 00802526562112: Patient Management System