Cl Electrode 20-27-0476F

GUDID 04580262010284

TOKYO BOEKI MEDISYS INC.

Multiple clinical chemistry analyser IVD, laboratory, automated
Primary Device ID04580262010284
NIH Device Record Key1196cb66-0d9a-46bf-a38a-f55d58099833
Commercial Distribution StatusIn Commercial Distribution
Brand NameCl Electrode
Version Model Number20-27-0476F
Catalog Number20-27-0476F
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
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@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 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104580262010284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGZElectrode, Ion-Specific, Chloride
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-23
Device Publish Date2019-09-30

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