GUDID 00840682115612

GE Vingmed Ultrasound AS

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00840682115612
• NIH Device Record Key: ff1d44df-c61a-4d8c-83fc-5fdff15df71f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: P2D
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682115612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160182

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

Devices Manufactured by GE Vingmed Ultrasound AS

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• 00195278640567 - Vscan: 2023-10-04 Vscan Air R2 for Android
• 00195278640574 - Vscan: 2023-10-04 Vscan Air R2 Upgrade kit
• 00195278660701 - Vscan: 2023-10-04 Vscan Air SL
• 00195278505330 - Vivid: 2022-09-28 Vivid E95 v206
• 00195278504302 - EchoPAC: 2022-08-31 MD EchoPAC Software Only v206
• 00195278504326 - EchoPAC: 2022-08-31 MD EchoPAC Plug-in v206
• 00195278505170 - Vivid: 2022-08-22 Vivid S70N v206 China