FORUM

GUDID 04049471070330

Intended Use: FORUM is a software system intended for use in storage, management, processing, and display of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications. FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.

Carl Zeiss Meditec AG

Patient health record information system application software

• Primary Device ID: 04049471070330
• NIH Device Record Key: 696b132b-1174-4315-a254-8f9e04f5a01c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORUM
• Version Model Number: 4
• Company DUNS: 314594680
• Company Name: Carl Zeiss Meditec AG
• 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: true
• 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	04049471070330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213527

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: 2023-04-24
• Device Publish Date: 2023-04-14

On-Brand Devices [FORUM]

• 04049471070026: This database entry covers UDI for SW Versions 4.1 and higher: (01)04049471070026(10)411 -> Vers
• 04049471070330: Intended Use: FORUM is a software system intended for use in storage, management, processing, a