uMI

GUDID 06971576832057

Shanghai United Imaging Healthcare Co., Ltd.

PET/CT system

• Primary Device ID: 06971576832057
• NIH Device Record Key: ac49e4b5-5178-4ef8-b4c0-32669767d8fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uMI
• Version Model Number: uMI 550
• Company DUNS: 421271328
• Company Name: Shanghai United Imaging Healthcare Co., Ltd.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971576832057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182237

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: 2020-07-17
• Device Publish Date: 2020-07-09

On-Brand Devices [uMI]

• 06971576832026: Positron Emission Tomography and Computed Tomography System
• 06971576832057: uMI 550
• 06971576832170: uMI Panorama 35
• 06971576832187: uMI Panorama GS