ORIGEN™ X4 CRT-D

GUDID 00802526534515

Cardiac Resynchronization Therapy Defibrillator

BOSTON SCIENTIFIC CORPORATION

Cardiac resynchronization therapy implantable defibrillator

• Primary Device ID: 00802526534515
• NIH Device Record Key: 636db328-a491-4414-ab98-b13e60626670
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORIGEN™ X4 CRT-D
• Version Model Number: G058
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	00802526534515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010012

FDA Product Code

• NIK: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-06
• Device Publish Date: 2017-11-03

On-Brand Devices [ORIGEN™ X4 CRT-D]

• 00802526534515: Cardiac Resynchronization Therapy Defibrillator
• 00802526534492: Cardiac Resynchronization Therapy Defibrillator