Medistim MiraQ Ultimate System MQU14022

GUDID 07070554101587

Medistim ASA

Cardiovascular ultrasound imaging system

• Primary Device ID: 07070554101587
• NIH Device Record Key: b69a48dc-e06c-4d39-87de-ec1cb007b658
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medistim MiraQ Ultimate System
• Version Model Number: MQU14022
• Catalog Number: MQU14022
• Company DUNS: 519521751
• Company Name: Medistim ASA
• 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	07070554101587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102595

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Medistim MiraQ Ultimate System]

• 07070554103932: MQU14012
• 07070554103925: MQU14011
• 07070554103895: MQU14001
• 07070554103765: MQU12011
• 07070554102973: MQU04011
• 07070554102959: MQU04001
• 07070554102829: MQU02011
• 07070554101587: MQU14022
• 07070554101471: MQU04122