Universal Viewer

GUDID 00195278379610

MD UV 8 MEDICAL DEVICE

GE HEALTHCARE

Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system Medical image management system

• Primary Device ID: 00195278379610
• NIH Device Record Key: c7ecf98e-0faa-46ba-9b32-4ce11b42784b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Viewer
• Version Model Number: 8
• 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	00195278379610 [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: 2021-07-23
• Device Publish Date: 2021-07-15

Devices Manufactured by GE HEALTHCARE

• 00840682124447 - Centricity: 2022-05-09 MD CPACS RA1000 4.0 MEDICAL DEVICE
• 00840682152754 - Graffiti: 2021-10-05 MD ACUTE VIRTUAL COLLABORATOR NOTIFY ME 1.0
• 00195278379610 - Universal Viewer: 2021-07-23MD UV 8 MEDICAL DEVICE
• 00195278379610 - Universal Viewer: 2021-07-23 MD UV 8 MEDICAL DEVICE
• 00840682145558 - Centricity: 2020-02-14
• 00840682102681 - CENTRICITY: 2020-02-04
• 00840682102988 - CENTRICITY: 2020-02-04
• 00840682103800 - CENTRICITY: 2020-02-04
• 00840682104807 - Centricity: 2020-02-04