Non-contact Tonometer HNT-1 HNT-1

GUDID 08800019600428

The Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the human eye.

Huvitz Co., Ltd.

Ophthalmic tonometer, battery-operated

• Primary Device ID: 08800019600428
• NIH Device Record Key: 09a5b070-9998-4f64-b7bf-60e4809ec058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-contact Tonometer HNT-1
• Version Model Number: HNT-1
• Catalog Number: HNT-1
• Company DUNS: 688154202
• Company Name: Huvitz 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +82314289100
• Email: svc@huvitz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800019600428 [Primary]

FDA Product Code

• HKX: Tonometer, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-12
• Device Publish Date: 2019-05-10

On-Brand Devices [Non-contact Tonometer HNT-1]

• 00880001960042: The Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the huma
• 08800019600428: The Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the huma