Vscan

GUDID 00840682147484

Vscan Air CL A1

GE Vingmed Ultrasound AS

Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 00840682147484
• NIH Device Record Key: 52ffb806-3243-40d7-b4aa-37c47881e2e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vscan
• Version Model Number: Air CL A1
• Company DUNS: 518870571
• Company Name: GE Vingmed Ultrasound AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682147484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202035

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-19
• Device Publish Date: 2021-02-11

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• 00840682147071: Vscan Air for iOS
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• 00195278640567: Vscan Air R2 for Android
• 00195278640550: Vscan Air R2 for iOS