Vscan

GUDID 00840682107853

GE Vingmed Ultrasound AS

General-purpose ultrasound imaging system

• Primary Device ID: 00840682107853
• NIH Device Record Key: 25b1b0c5-d08f-4261-a4bc-7ff595bbdbd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vscan
• Version Model Number: v1.2
• Company DUNS: 518870571
• Company Name: GE Vingmed Ultrasound AS
• 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

Customer Support Contacts

• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682107853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092756

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-01

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• 00840682107891: Dual Probe
• 00840682107853: v1.2
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• 00840682147101: Vscan Air for Android
• 00840682147071: Vscan Air for iOS
• 00195278660701: Vscan Air SL
• 00195278640574: Vscan Air R2 Upgrade kit
• 00195278640567: Vscan Air R2 for Android
• 00195278640550: Vscan Air R2 for iOS