S-ICD® System Patient Screening Tool

GUDID 00802526524806

Patient Screening Tool

CAMERON HEALTH, INC.

Cardiac pulse generator programmer

• Primary Device ID: 00802526524806
• NIH Device Record Key: 8d7f6e53-9265-4108-8aa8-28ff86fb9b64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-ICD® System Patient Screening Tool
• Version Model Number: 4744
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526524806 [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: false

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

Devices Manufactured by CAMERON HEALTH, INC.

• 00802526542206 - Q TECH: 2018-09-11 Programmer for the S-ICD® System
• 00802526521300 - SQ-RX® PULSE GENERATOR: 2018-07-06 SQ-RX Pulse Generator
• 00802526524806 - S-ICD® System Patient Screening Tool: 2018-07-06Patient Screening Tool
• 00802526524806 - S-ICD® System Patient Screening Tool: 2018-07-06 Patient Screening Tool
• 00802526531019 - The Q-GUIDE™ Electrode Insertion Tool: 2018-07-06 Electrode Insertion Tool
• 00802526531033 - S-ICD® System Magnet: 2018-07-06 Magnet
• 00802526542244 - Q-TECH™: 2018-07-06 Power Supply for S-ICD Programmer 3200
• 00802526553707 - HP OFFICEJET 100 Mobile Printer: 2018-07-06 Printer
• 00802526562808 - SQ-RX® PULSE GENERATOR: 2018-07-06 SQ-RX Pulse Generator