AMRA Profiler 4

GUDID 07350140460312

AMRA Medical AB

Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system

• Primary Device ID: 07350140460312
• NIH Device Record Key: cc634a61-23da-49fb-8e9c-64d63b6b1608
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMRA Profiler 4
• Version Model Number: US031
• Company DUNS: 350089500
• Company Name: AMRA Medical AB
• 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: false
• 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: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com
• Phone: +4613162600
• Email: support@amramedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350140460312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211983

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: 2022-02-23
• Device Publish Date: 2022-02-15