Ashvins variant HEYEX 2 / HEYEX PACS

GUDID 04260648620046

MedicalCommunications GmbH

Ophthalmology PACS software

• Primary Device ID: 04260648620046
• NIH Device Record Key: 13d43aa8-e1fa-438a-83f0-fa01fb1de0d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ashvins variant HEYEX 2 / HEYEX PACS
• Version Model Number: 2.6
• 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	04260648620046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200132

FDA Product Code

• NFJ: System, Image Management, Ophthalmic

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: 2023-03-06
• Device Publish Date: 2023-02-24

On-Brand Devices [Ashvins variant HEYEX 2 / HEYEX PACS]

• 04260648620015: 2.5
• 04260648620046: 2.6
• 04260648620060: 2.6.5 (Build 2167)