Cleaning Solution 20-27-04789

GUDID 04580262010321

TOKYO BOEKI MEDISYS INC.

Multiple clinical chemistry analyser IVD, laboratory
Primary Device ID04580262010321
NIH Device Record Key3f843dd8-e4d1-44d7-b4a2-65cf7403f446
Commercial Distribution StatusIn Commercial Distribution
Brand NameCleaning Solution
Version Model Number20-27-0479
Catalog Number20-27-04789
Company DUNS696265656
Company NameTOKYO BOEKI MEDISYS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104580262010321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-26
Device Publish Date2023-12-18

Devices Manufactured by TOKYO BOEKI MEDISYS INC.

04580262010314 - Calibrator 22023-12-26
04580262010321 - Cleaning Solution2023-12-26
04580262010321 - Cleaning Solution2023-12-26
04580262040076 - Calibrator 22023-12-19
04580262049802 - IMMTOX 2702021-12-06 IMMTOX 270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures
04580262049819 - DZ-Lite c2702021-12-06 DZ-Lite c270 is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedur
04580262049826 - MyeLyte Touch2021-12-06 MyeLyte Touch is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedu
04580262010208 - Alkaline Washing Solution2019-12-23
04580262010222 - Acid Washing Solution2019-12-23

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