Urine Calibrator Set

Basic Information

• Brand Name: Urine Calibrator Set
• Primary DI: 04580262010338
• Version / Model: 20-27-0480
• Catalog Number: 20-27-0480
• Company Name: TOKYO BOEKI MEDISYS INC.
• Labeler DUNS: 696265656
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-30
• Public Version: 7
• Public Version Date: 2024-02-02
• Public Version Status: Update
• Public Device Record Key: 32a9eb42-acec-437e-99f7-19c12f1a231f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52867	Multiple electrolyte IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04580262010338	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K040958	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius