LATITUDE™ Programming System

GUDID 00802526610110

LATITUDE ™ Programming System

BOSTON SCIENTIFIC CORPORATION

Cardiac pulse generator programmer

• Primary Device ID: 00802526610110
• NIH Device Record Key: e34bcaed-2f67-4097-9f20-71e66bd7793f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LATITUDE™ Programming System
• Version Model Number: 3300
• 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	00802526610110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P910077

FDA Product Code

• OSR: Pacemaker/icd/crt non-implanted components

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: 2019-11-12
• Device Publish Date: 2019-11-04

On-Brand Devices [LATITUDE™ Programming System]

• 00802526585005: LATITUDE ™ Programming System
• 00802526610110: LATITUDE ™ Programming System
• 00802526610202: LATITUDE ™ Programming System
• 00802526608513: LATITUDE ™ Programming System
• 00802526616105: Programming System
• 00802526620201: Programming System
• 00802526621215: Programming System
• 00802526622908: Programming System
• 00802526622601: Programming System