4D View

GUDID 00840682122788

GE Healthcare Austria GmbH & Co OG

Ultrasound imaging system operation software

• Primary Device ID: 00840682122788
• NIH Device Record Key: 52dafedd-0ce3-4253-8f66-1474d5ef4da5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4D View
• Version Model Number: 17
• Company DUNS: 300599979
• Company Name: GE Healthcare Austria GmbH & Co OG
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682122788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131118

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-08

On-Brand Devices [4D View]

• 00840682137621: 18
• 00840682122788: 17
• 00840682102780: 16