RESONATE™ HF ICD DR

GUDID 00802526588310

Implantable Cardioverter Defibrillator DR

BOSTON SCIENTIFIC CORPORATION

Dual-chamber implantable defibrillator

• Primary Device ID: 00802526588310
• NIH Device Record Key: c857ceab-ce39-4bcd-a267-94c0669ea1ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESONATE™ HF ICD DR
• Version Model Number: D533
• 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	00802526588310 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-20
• Device Publish Date: 2021-07-12

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 00191506055752 - IceSeed™: 2025-02-27 Cryoablation Needle
• 00191506055769 - IceSphere™: 2025-02-27 Cryoablation Needle
• 00191506055776 - IceRod™: 2025-02-27 Cryoablation Needle
• 00191506060138 - OverStitch™: 2025-02-25 Polypropylene Suture
• 00191506049157 - X-Tack™: 2025-02-25 Endoscopic HeliX Tacking System (Gastric)
• 00191506049164 - X-Tack™: 2025-02-25 Endoscopic HeliX Tacking System (Colonic)
• 00191506049188 - NA: 2025-02-25 Suture Cinch - Long
• 00191506060046 - OverStitch™: 2025-02-25 Suture Cinch