INOGEN™ MINI ICD DR

GUDID 00802526533846

Implantable Cardioverter Defibrillator DR

BOSTON SCIENTIFIC CORPORATION

Dual-chamber implantable defibrillator

• Primary Device ID: 00802526533846
• NIH Device Record Key: c24004b2-30d6-4d0b-9f64-ec8d7b1ed670
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INOGEN™ MINI ICD DR
• Version Model Number: D013
• 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	00802526533846 [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: 2014-09-24

On-Brand Devices [INOGEN™ MINI ICD DR]

• 00802526533846: Implantable Cardioverter Defibrillator DR
• 00802526533822: Implantable Cardioverter Defibrillator DR