KOWA AP-7000

GUDID 04987646805113

KOWA AP-7000 is an automatic perimeter to perform perimetry examinations and to display and output examination results. Static quantitative perimetry

KOWA COMPANY,LTD.

Perimeter, automatic

• Primary Device ID: 04987646805113
• NIH Device Record Key: d00a06db-8137-490a-aaf8-c83984197800
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOWA AP-7000
• Version Model Number: FT10K
• Company DUNS: 692281073
• Company Name: KOWA COMPANY,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: 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 Dimensions

• Height: 700 Millimeter
• Depth: 430 Millimeter
• Width: 730 Millimeter
• Weight: 26 Kilogram

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987646805113 [Primary]

FDA Product Code

• HPT: Perimeter, Automatic, 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: 2019-02-08
• Device Publish Date: 2019-01-08

Devices Manufactured by KOWA COMPANY,LTD.

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• 04987646810032 - KOWA SL-19: 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu
• 04987646810049 - KOWA SL-19: 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu
• 04987646810056 - KOWA SL-19: 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu
• 04987646810063 - KOWA SL-19: 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu
• 04987646810070 - KOWA SL-19: 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu
• 04987646809128 - KOWA nonmyd AF: 2020-01-23 KOWA nonmyd AF is intended for use with retinal image capturing without requiring the patients to take any mydriatic.
• 04987646807728 - KOWA DR-1α: 2019-06-18 The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician