Critical Care Suite

GUDID 00195278789365

Critical Care Suite 2.1, Designated Medical Device

GE MEDICAL SYSTEMS, INC.

X-ray image interpretive software

• Primary Device ID: 00195278789365
• NIH Device Record Key: 3fc3b3b8-a015-4992-877a-09fe30713923
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Critical Care Suite
• Version Model Number: 2.1
• Company DUNS: 809785715
• Company Name: GE MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278789365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223491

FDA Product Code

• QBS: Radiological Computer Assisted Detection/Diagnosis Software For Fracture

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: 2023-10-27
• Device Publish Date: 2023-10-19

On-Brand Devices [Critical Care Suite]

• 00840682146340: 1.0
• 00840682147231: Designated Medical Device, Critical Care Suite PACS 1.0
• 00195278217981: Critical Care Suite 2.0, Designated Medical Device
• 00195278789365: Critical Care Suite 2.1, Designated Medical Device