Calibrator 2 20-27-0478

GUDID 04580262010314

TOKYO BOEKI MEDISYS INC.

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• Primary Device ID: 04580262010314
• NIH Device Record Key: ff2a7427-f863-4286-bdef-6ea2b0a7074b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calibrator 2
• Version Model Number: 20-27-0478
• Catalog Number: 20-27-0478
• 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 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	04580262010314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040958

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture

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

On-Brand Devices [Calibrator 2]

• 04580262040076: 30-27-0905
• 04580262010314: 20-27-0478