GUDID 00840682115582

GE Vingmed Ultrasound AS

Oesophageal ultrasound imaging transducer, reusable

• Primary Device ID: 00840682115582
• NIH Device Record Key: e0cf364f-9672-45d1-b02f-9e3050f060d7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6Tc
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682115582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142323

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: 2016-07-15

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• 00195278504302 - EchoPAC: 2022-08-31 MD EchoPAC Software Only v206
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• 00195278505170 - Vivid: 2022-08-22 Vivid S70N v206 China