Medistim System Activation Card CV000441

GUDID 7070554104182

Medistim ASA

Cardiovascular ultrasound imaging system

• Primary Device ID: 7070554104182
• NIH Device Record Key: 74d3c3c8-79e8-4a9b-b695-e692c223734d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medistim System Activation Card
• Version Model Number: CV000441
• Catalog Number: CV000441
• 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: 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	07070554104175 [Primary]
GS1	7070554104182 [Package]; Contains: 07070554104175; Package: [5 Units]; In Commercial Distribution

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: 2016-09-23

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