Guardian Programmer Model PROG-004 0217-2100-004#P18

GUDID 00850012625162

PROG-004 Kit (US)

Avertix Medical Inc.

Implantable cardiac device management application software

• Primary Device ID: 00850012625162
• NIH Device Record Key: 6f28c94e-0289-41ec-8765-e32547a68ad5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian Programmer Model PROG-004
• Version Model Number: 0217-2100-004#P18
• Catalog Number: 0217-2100-004#P18
• Company DUNS: 171391779
• Company Name: Avertix Medical 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012625162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150009

FDA Product Code

• QBI: Acute Coronary Syndrome Event Detector

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-13
• Device Publish Date: 2025-03-05