Medistim MiraQ Vascular System MQV14001

GUDID 07070554103581

Medistim ASA

Cardiovascular ultrasound imaging system

• Primary Device ID: 07070554103581
• NIH Device Record Key: 98ca2241-c281-4f8f-a906-20e83d888b32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medistim MiraQ Vascular System
• Version Model Number: MQV14001
• Catalog Number: MQV14001
• 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	07070554103581 [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 Vascular System]

• 07070554103628: MQV14012
• 07070554103604: MQV14010
• 07070554103581: MQV14001
• 07070554103437: MQV12010
• 07070554102768: MQV04102
• 07070554102676: MQV04001
• 07070554102614: MQV02111
• 07070554101549: MQV14022
• 07070554101525: MQV14020
• 07070554101396: MQV04122
• 07070554101372: MQV04120
• 07070554101358: MQV04010
• 07070554101334: MQV02010
• 07070554103444: MQV12011
• 07070554103611: MQV14011
• 07070554102690: MQV04011