FDA.reportPublic FDA data

Calibrator 2 (140mL)

Primary DI
04580262028227
Brand
Calibrator 2 (140mL)
Company
TOKYO BOEKI MEDISYS INC.
Model
30-27-0905F
Catalog number
30-27-0905F
Published
2019-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040958000PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240Tokyo Boeki Medical System , Ltd.2005-02-15JJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580262028227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580262028227045802620282274580262028227

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratory, automatedAn electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+81425872965kenji.takeuchi@tb-medisys.co.jp

Regulatory Flags#

DUNS number
696265656
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580262010345Diluent for Urine20-27-048220-27-04822019-09-30
04580262010314Calibrator 220-27-047820-27-04782023-12-18
04580262010321Cleaning Solution20-27-047920-27-04792023-12-18
04580262040076Calibrator 230-27-090530-27-09052019-09-30
04580262049802IMMTOX 27060-01-900160-01-90012021-11-26
04580262049819DZ-Lite c27060-01-900260-01-90022021-11-26
04580262049826MyeLyte Touch60-01-900360-01-90032021-11-26
04580262010208Alkaline Washing SolutionSP2208SP22082019-09-30
04580262010222Acid Washing SolutionSP2209SP22092019-09-30
04580262010291Reference Electrode20-27-047320-27-04732019-09-30
04580262010307Calibrator 120-27-047720-27-04772019-09-30
04580262010338Urine Calibrator Set20-27-048020-27-04802019-09-30
04580262010352Dialysis Calibrator20-27-048320-27-04832019-09-30
04580262016019Calibrator SET A, B60-22-026360-22-02632019-09-30
04580262046511ISE Cleaner (1%)50-27-078150-27-07812019-09-30
04580262046528ISE Cleaner (5%)50-27-078250-27-07822019-09-30
04580262046818Alkaline Washing Solution50-24-074750-24-07472019-09-30
04580262046825Acid Washing Solution50-24-074850-24-07482019-09-30
04580262016002BIOLIS 30i60-01-000160-01-00012016-09-23
04580262010260Na (Sodium) Electrode20-27-047420-27-04742019-09-30

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