GUDID 00840682115766

GE Vingmed Ultrasound AS

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00840682115766
• NIH Device Record Key: a3eed5ac-17c9-475a-8313-08200ccbd773
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: P2D KE100005
• 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

• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682115766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121063

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

• 00195278951700 - EchoPAC: 2025-08-18 MD EchoPAC Software Only v210
• 00195278951717 - EchoPAC: 2025-08-18 MD EchoPAC Plug-In v210
• 00195278916938 - Vivid: 2025-08-15 Vivid Pioneer v210
• 00195278884725 - Vscan: 2025-05-30 Vscan Air R3 for Android
• 00195278884749 - Vscan: 2025-05-30 Vscan Air R3 for iOS
• 00195278640550 - Vscan: 2023-10-04 Vscan Air R2 for iOS
• 00195278640567 - Vscan: 2023-10-04 Vscan Air R2 for Android
• 00195278640574 - Vscan: 2023-10-04 Vscan Air R2 Upgrade kit