Medistim System Activation Card CV000446

GUDID 07070554104854

Medistim ASA

Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system

• Primary Device ID: 07070554104854
• NIH Device Record Key: 06c93207-7117-43bb-974f-3e9057c2e2d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medistim System Activation Card
• Version Model Number: CV000446
• Catalog Number: CV000446
• 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: true
• Lot Batch: true
• 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	07070554104816 [Primary]
GS1	07070554104854 [Package]; Contains: 07070554104816; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102595

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

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: 2021-10-19
• Device Publish Date: 2021-10-11

On-Brand Devices [Medistim System Activation Card]

• 07070554104243: CV000445
• 07070554104236: CV000444
• 7070554104229: CV000443
• 7070554104205: CV000442
• 7070554104182: CV000441
• 07070554104144: CV000309
• 7070554104137: CV000307
• 07070554104113: CV000305
• 7070554104090: CV000303
• 7070554104076: CV000301
• 7070554104052: CV000300
• 07070554104885: CV000449
• 07070554104878: CV000448
• 07070554104861: CV000447
• 07070554104854: CV000446