Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert

GUDID 05745000308071

Cercare Medical A/S

Radiological PACS software

• Primary Device ID: 05745000308071
• NIH Device Record Key: 9fd946ee-705f-49b2-8f52-e7928052ce98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
• Version Model Number: 2023-06-01
• Company DUNS: 305457217
• Company Name: Cercare Medical A/S
• 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: false
• 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	05745000308071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202793

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: 2023-11-17
• Device Publish Date: 2023-11-09

On-Brand Devices [Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert]

• 05745000308071: 2023-06-01
• 05745000308125: Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 14
• 05745000308170: Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 15