EMBLEM™ MRI S-ICD

GUDID 00802526584404

Subcutaneous Implantable Cardioverter Defibrillator

BOSTON SCIENTIFIC CORPORATION

Single-chamber implantable defibrillator

• Primary Device ID: 00802526584404
• NIH Device Record Key: 1cf23cf9-a966-422f-9284-0e8c6eda8547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMBLEM™ MRI S-ICD
• Version Model Number: A219
• 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	00802526584404 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-17
• Device Publish Date: 2016-08-17

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729838005 - Capio SLIM: 2024-11-13 Suture Capturing Device
• 00191506043193 - FARAWAVE™ NAV: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043209 - FARAWAVE™ NAV: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043216 - FARAWAVE™: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043223 - FARAWAVE™: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043698 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator
• 00191506043704 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator
• 00191506043711 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator