Medistim MiraQ Cardiac System MQC12001

GUDID 07070554101488

Medistim ASA

Cardiovascular ultrasound imaging system

• Primary Device ID: 07070554101488
• NIH Device Record Key: 26e75b46-c038-47c3-bd7d-7c7dfd81b6d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medistim MiraQ Cardiac System
• Version Model Number: MQC12001
• Catalog Number: MQC12001
• 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	07070554101488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102595

FDA Product Code

• DPW: Flowmeter, Blood, Cardiovascular

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 Cardiac System]

• 07070554103307: MQC14022
• 07070554103277: MQC14012
• 07070554102492: MQC04122
• 07070554101501: MQC14002
• 07070554101495: MQC14001
• 07070554101488: MQC12001
• 07070554101327: MQC04102
• 07070554101303: MQC04001
• 07070554101273: MQC02001