mfiVerse

GUDID 00860059002109

MULTIFUNCTIONAL IMAGING, LLC

PET system application software

• Primary Device ID: 00860059002109
• NIH Device Record Key: e691efcb-63f6-44b8-877c-c24072422db7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mfiVerse
• Version Model Number: v1
• Company DUNS: 078299996
• Company Name: MULTIFUNCTIONAL IMAGING, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860059002109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173512

FDA Product Code

• KPS: System, Tomography, Computed, Emission

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: 2019-10-15
• Device Publish Date: 2019-10-07