SQ-RX® PULSE GENERATOR

GUDID 00802526521300

SQ-RX Pulse Generator

CAMERON HEALTH, INC.

Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator

• Primary Device ID: 00802526521300
• NIH Device Record Key: f5c4e362-9ab5-4b78-88d6-45be960ceba0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SQ-RX® PULSE GENERATOR
• Version Model Number: 1010
• Company DUNS: 017134557
• Company Name: CAMERON HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00802526521300 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [SQ-RX® PULSE GENERATOR]

• 00802526562808: SQ-RX Pulse Generator
• 00802526521300: SQ-RX Pulse Generator