CAAS A-Valve

GUDID 08056304454270

Pie Medical Imaging B.V.

Radiology DICOM image processing application software

• Primary Device ID: 08056304454270
• NIH Device Record Key: bc12598a-7b23-455f-be16-0441c879b722
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAAS A-Valve
• Version Model Number: 2.1
• Company DUNS: 413761941
• Company Name: Pie Medical Imaging B.V.
• 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: true
• 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	08056304454270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143044

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-12-04
• Device Publish Date: 2020-05-19

On-Brand Devices [CAAS A-Valve]

• 08056304451156: 2.0
• 08056304451149: 1.0
• 08056304454270: 2.1