Monarch

GUDID 00851354007036

MERIDIAN MEDICAL SYSTEMS, LLC

Flat panel x-ray detector integration unit

• Primary Device ID: 00851354007036
• NIH Device Record Key: 6137c826-d299-427a-b3d0-471bc4b21e98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch
• Version Model Number: RT 204
• 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

Customer Support Contacts

• Phone: 844-628-5638
• Email: sales@meridianmed.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851354007036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140251

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: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-24

On-Brand Devices [Monarch]

• 00851354007142: RT 311
• 00851354007135: RT 310
• 00851354007128: RT 309
• 00851354007111: RT 308
• 00851354007104: RT 307
• 00851354007098: RT 306
• 00851354007081: RT 305
• 00851354007074: RT 304
• 00851354007067: RT 303
• 00851354007050: RT 302
• 00851354007043: RT 301
• 00851354007036: RT 204
• 00851354007029: RT 203
• 00851354007012: RT 202
• 00851354007005: RT 201