maging System HIS-5000U HIS-5000U

GUDID 08800019600121

imaging system is intended for help observation and recording of eye using a slit lamp

Huvitz Co., Ltd.

Multidisciplinary medical image management software

• Primary Device ID: 08800019600121
• NIH Device Record Key: 511e2c1a-a19e-4d3a-9ec7-f6831aa49bfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: maging System HIS-5000U
• Version Model Number: HIS-5000U
• Catalog Number: HIS-5000U
• Company DUNS: 688154202
• Company Name: Huvitz Co., Ltd.
• 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: 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	08800019600121 [Primary]

FDA Product Code

• NVV: Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

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: 2019-05-20
• Device Publish Date: 2019-05-10

Devices Manufactured by Huvitz Co., Ltd.

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• 08800019600916 - Digital Refractor HDR-7100P: 2023-09-01 The HUVITZ Digital Refractor HDR-7100P system is a computerized auto refractor used for subjective refraction by regarding the p
• 08800019600923 - Auto Ref/Keratometer HRK-8100A: 2023-09-01 Auto Ref/Keratometer HRK-8100A is intended to provide the information of Spherical, Cylindrical and Axis while measuring the ref
• 08800019600411 - Applanation Tonometer HT-5000: 2023-06-20 Applanation Tonometer HT-5000