Ashvins

GUDID 04260648620053

MedicalCommunications GmbH

Ophthalmology PACS software

• Primary Device ID: 04260648620053
• NIH Device Record Key: 8469e536-dbdb-4ceb-964d-6c98b566579b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ashvins
• Version Model Number: 2023 (Build 2167)
• Company DUNS: 314721366
• Company Name: MedicalCommunications GmbH
• 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	04260648620053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200132

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: 2024-07-17
• Device Publish Date: 2024-07-09

On-Brand Devices [Ashvins]

• 04260648620022: 2021 (Build 1920)
• 04260648620039: 2023 (Build 2088)
• 04260648620053: 2023 (Build 2167)