N/A

GUDID 04582275270051

KONAN MEDICAL USA, INC.

Pupillograph

• Primary Device ID: 04582275270051
• NIH Device Record Key: 8d5127a3-8c99-47ec-913a-a8887c211fca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: Eyekinetix
• Company DUNS: 788439219
• Company Name: KONAN MEDICAL USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582275270051 [Primary]

FDA Product Code

• HRI: Pupillograph

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: 2019-09-17
• Device Publish Date: 2019-09-09

Devices Manufactured by KONAN MEDICAL USA, INC.

• 04582275270068 - NA: 2023-06-23
• 04582275270051 - N/A: 2019-09-17
• 04582275270051 - N/A: 2019-09-17
• 04582275270020 - NA: 2018-07-06
• 04582275270037 - NA: 2018-03-29
• 04582275270044 - NA: 2018-03-29