ZOOM® LATITUDE®

GUDID 00802526562600

programmer/recorder/monitor

BOSTON SCIENTIFIC CORPORATION

Cardiac pulse generator programmer

• Primary Device ID: 00802526562600
• NIH Device Record Key: fe8f2b01-34af-44d0-8b62-e3c296f3ef63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOOM® LATITUDE®
• Version Model Number: 3120
• 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: false
• Serial Number: true
• 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	00802526562600 [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 [ZOOM® LATITUDE®]

• 00802526606366: programmer/recorder/monitor
• 00802526604584: programmer/recorder/monitor
• 00802526602900: programmer/recorder/monitor
• 00802526582004: programmer/recorder/monitor
• 00802526579707: programmer/recorder/monitor
• 00802526575303: programmer/recorder/monitor
• 00802526564703: programmer/recorder/monitor
• 00802526562600: programmer/recorder/monitor
• 00802526611322: programmer/recorder/monitor