Cleaning Solution 20-27-04789

GUDID 04580262010321

TOKYO BOEKI MEDISYS INC.

Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system

• Primary Device ID: 04580262010321
• NIH Device Record Key: 3f843dd8-e4d1-44d7-b4a2-65cf7403f446
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cleaning Solution
• Version Model Number: 20-27-0479
• Catalog Number: 20-27-04789
• Company DUNS: 696265656
• Company Name: TOKYO BOEKI MEDISYS INC.
• 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: true
• 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

Customer Support Contacts

• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp
• Phone: +81425872965
• Email: hiroshi.miyazato@tb-medisys.co.jp

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04580262010321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040958

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical 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: 2023-12-26
• Device Publish Date: 2023-12-18

Devices Manufactured by TOKYO BOEKI MEDISYS INC.

• 04580262010314 - Calibrator 2: 2023-12-26
• 04580262010321 - Cleaning Solution: 2023-12-26
• 04580262010321 - Cleaning Solution: 2023-12-26
• 04580262040076 - Calibrator 2: 2023-12-19
• 04580262049802 - IMMTOX 270: 2021-12-06 IMMTOX 270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures
• 04580262049819 - DZ-Lite c270: 2021-12-06 DZ-Lite c270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedur
• 04580262049826 - MyeLyte Touch: 2021-12-06 MyeLyte Touch is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedu
• 04580262010208 - Alkaline Washing Solution: 2019-12-23
• 04580262010222 - Acid Washing Solution: 2019-12-23