Paragon 2

GUDID 00851354007159

Paragon Mobile with 14 x 17 Wireless Panel

MERIDIAN MEDICAL SYSTEMS, LLC

Mobile basic diagnostic x-ray system, digital

• Primary Device ID: 00851354007159
• NIH Device Record Key: c3395e42-307f-4180-a3d2-0c93c9c8e8f8
• Commercial Distribution Discontinuation: 2017-11-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Paragon 2
• Version Model Number: RT312
• Company DUNS: 078759601
• Company Name: MERIDIAN MEDICAL SYSTEMS, LLC
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00851354007159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162687

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2017-11-03

Devices Manufactured by MERIDIAN MEDICAL SYSTEMS, LLC

• 00851354007005 - Monarch: 2019-02-21
• 00851354007012 - Monarch: 2019-02-21
• 00851354007029 - Monarch: 2019-02-21
• 00851354007036 - Monarch: 2019-02-21
• 00851354007043 - Monarch: 2019-02-21
• 00851354007050 - Monarch: 2019-02-21
• 00851354007067 - Monarch: 2019-02-21
• 00851354007074 - Monarch: 2019-02-21