Airdoc

GUDID 06976107790301

Changsha Airdoc Health Technology Co., Ltd.

Ophthalmic fundus camera

• Primary Device ID: 06976107790301
• NIH Device Record Key: 65950d36-b314-4d9b-a10f-d9f10e857d01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Airdoc
• Version Model Number: AI-FD16aN
• Company DUNS: 848523425
• Company Name: Changsha Airdoc Health Technology Co., Ltd.
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	06976107790301 [Primary]

FDA Product Code

• PJZ: Camera, Ophthalmic, General-Use

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: 2024-10-07
• Device Publish Date: 2024-09-27