Medistim VeriQCSystem VQ4122C

GUDID 07070554101266

Medistim ASA

Cardiovascular ultrasound imaging system

• Primary Device ID: 07070554101266
• NIH Device Record Key: d8c5722e-b74d-4df0-8e98-c115b93a9bbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medistim VeriQCSystem
• Version Model Number: VQ4122C
• Catalog Number: VQ4122C
• 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	07070554101266 [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

Devices Manufactured by Medistim ASA

• 07070554103444 - Medistim MiraQ Vascular System: 2024-04-22
• 07070554104854 - Medistim System Activation Card: 2021-10-19
• 07070554104861 - Medistim System Activation Card: 2021-10-19
• 07070554104878 - Medistim System Activation Card: 2021-10-19
• 07070554104885 - Medistim System Activation Card: 2021-10-19
• 07070554104489 - Medistim Interconnect Cable: 2020-11-09
• 07070554104502 - Medistim Interconnect Cable: 2020-11-09
• 07070554104519 - Medistim Interconnect Cable: 2020-11-09