Promaxo MRI System PR071-001-M

GUDID 00860006901110

Magnetic Resonance Imaging System, Magnet Cart

Promaxo, Inc.

Full-body MRI system, permanent magnet

• Primary Device ID: 00860006901110
• NIH Device Record Key: 9ab0949d-069b-4a43-a9f0-6372fa4fe7e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Promaxo MRI System
• Version Model Number: PR071-001-M
• Catalog Number: PR071-001-M
• Company DUNS: 103665187
• Company Name: Promaxo, 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: 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	00860006901110 [Primary]

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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: 2022-04-27
• Device Publish Date: 2022-04-19

On-Brand Devices [Promaxo MRI System]

• 00860006901127: Magnetic Resonance Imaging System, Auxiliary Rack
• 00860006901110: Magnetic Resonance Imaging System, Magnet Cart