Universal Viewer

GUDID 00195278644039

MD UV 8.1 MEDICAL DEVICE

GE HEALTHCARE

Medical image management system

• Primary Device ID: 00195278644039
• NIH Device Record Key: 8d7f54dc-e5d0-40b6-8458-cafa5c6cbd7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Viewer
• Version Model Number: 8.1
• Company DUNS: 054324257
• Company Name: GE HEALTHCARE
• 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	00195278644039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211312

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: 2024-10-10
• Device Publish Date: 2024-10-02

On-Brand Devices [Universal Viewer]

• 00195278379610: MD UV 8 MEDICAL DEVICE
• 00195278644039: MD UV 8.1 MEDICAL DEVICE