GUDID 00697077002459

Amico Diagnostic Incorporated

Direct ophthalmoscope, line-powered

• Primary Device ID: 00697077002459
• NIH Device Record Key: 58e4e40f-cbd6-444e-a462-89edafb76062
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DS-UA1-CHFL-DLO
• Company DUNS: 203163290
• Company Name: Amico Diagnostic Incorporated
• 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: true
• 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	00697077002459 [Primary]

FDA Product Code

• HLI: Ophthalmoscope, 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: 2019-02-22
• Device Publish Date: 2019-01-22

Devices Manufactured by Amico Diagnostic Incorporated

• 00697077003050 - Amico Diagnostic, Inc.: 2024-09-26 Diagnostic Station Ophthalmoscope & Otoscope LED, Spec Dispenser, Aneroid & Adult Cuff, Thermometer, Grey Wallboard Ophthalmosco
• 00697077003036 - NA: 2024-07-02
• 00697077003029 - NA: 2024-05-10
• 00697077002237 - NA: 2023-08-04
• 00697077002985 - NA: 2023-08-04
• 00697077002992 - NA: 2023-08-04
• 00697077003005 - NA: 2023-08-04
• 00697077003012 - NA: 2023-08-04