Cercare Medical Neurosuite with Capillary Function

GUDID 05745000308064

Cercare Medical A/S

Radiological PACS software

• Primary Device ID: 05745000308064
• NIH Device Record Key: 240c1207-3ca7-45d6-946d-448175c77e94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cercare Medical Neurosuite with Capillary Function
• 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	05745000308064 [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 with Capillary Function]

• 05745000308019: CMN with Capillary Function (MR)
• 05745000308064: 2023-06-01
• 05745000308118: Cercare Medical Neurosuite with Capillary Function ver. 14
• 05745000308163: Cercare Medical Neurosuite with Capillary Function ver. 15
• 05745000308217: Cercare Medical Neurosuite with Capillary Function ver. 16
• 05745000308262: Cercare Medical Neurosuite with Capillary Function ver. 17