RESONATE™ EL ICD DR

GUDID 00802526588075

Implantable Cardioverter Defibrillator DR

BOSTON SCIENTIFIC CORPORATION

Dual-chamber implantable defibrillator

• Primary Device ID: 00802526588075
• NIH Device Record Key: 70665cbf-1777-4b94-8b32-1737b59651e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESONATE™ EL ICD DR
• Version Model Number: D433
• 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	00802526588075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960040

FDA Product Code

• LWS: Implantable cardioverter defibrillator (non-CRT)

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: 2017-09-27

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729839835 - Direxion™ HI-FLO™ Transend™-18 System: 2025-01-23 Pre-Loaded Torqueable Microcatheter
• 08714729269915 - Electrophysiology Cable: 2025-01-15 Sterile Cable
• 08714729877868 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877875 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877882 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877899 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877905 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter
• 08714729877912 - Radia™: 2025-01-08 Bidirectional Steerable Diagnostic Catheter