Reference Electrode 20-27-0473F

GUDID 04580262010291

TOKYO BOEKI MEDISYS INC.

Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated 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 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 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 Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD Reference electrode IVD

• Primary Device ID: 04580262010291
• NIH Device Record Key: 16cfd5d8-480f-4815-b2d5-02f73970d69c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reference Electrode
• Version Model Number: 20-27-0473F
• Catalog Number: 20-27-0473F
• 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: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@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
• 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 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04580262010291 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-09-30

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