Urine Calibrator Set 20-27-0480

GUDID 04580262010338

TOKYO BOEKI MEDISYS INC.

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• Primary Device ID: 04580262010338
• NIH Device Record Key: 32a9eb42-acec-437e-99f7-19c12f1a231f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urine Calibrator Set
• Version Model Number: 20-27-0480
• Catalog Number: 20-27-0480
• 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	04580262010338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040958

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture
• 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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