GUDID 00802526575907

Log Data Card for the Model 3200 EMBLEM™ S-ICD Programmer

BOSTON SCIENTIFIC CORPORATION

Cardiac pulse generator programmer

• Primary Device ID: 00802526575907
• NIH Device Record Key: a7de1b70-237c-4eac-9bc3-1659bed7c12c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3205
• 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	00802526575907 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110042

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: 2016-02-16

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