RetCam Envision 61-000300

GUDID 05713315011597

RetCam Envision system with FA

Natus Medical Denmark ApS

Ophthalmic fundus camera

• Primary Device ID: 05713315011597
• NIH Device Record Key: 14273099-fe74-4def-85a8-3c3e99f23cae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RetCam Envision
• Version Model Number: 61-000300
• Catalog Number: 61-000300
• Company DUNS: 306633756
• Company Name: Natus Medical Denmark ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315011597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203500

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

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: 2026-02-18
• Device Publish Date: 2026-02-10

On-Brand Devices [RetCam Envision]

• 05713315011962: RetCam Envision System Basix
• 05713315011948: RetCam Envision Portrait Lens
• 05713315011931: RetCam Envision 130 Degrees Lens
• 05713315011924: Lens, 80 Degrees
• 05713315011641: FA Upgrade kit for - RetCam Envision without FA
• 05713315011597: RetCam Envision system with FA