Invenia

GUDID 00840682141109

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

Ultrasound imaging system workstation

• Primary Device ID: 00840682141109
• NIH Device Record Key: 1da103d2-98e1-4cf9-9efc-2bb228d12c93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invenia
• Version Model Number: ABUS Viewer
• Company DUNS: 078863378
• Company Name: GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
• 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	00840682141109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180641

FDA Product Code

• LLZ: System, image processing, radiological

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: 2018-08-27
• Device Publish Date: 2018-07-27

On-Brand Devices [Invenia]

• 00840682100090: ABUS Review Software
• 00840682141161: ABUS 2.0
• 00840682141109: ABUS Viewer
• 00840682100038: ABUS Workstation
• 00840682100021: ABUS Scan Station
• 00840682100014: ABUS System