CTO-40C CL

Basic Information

• Brand Name: CTO-40C CL
• Primary DI: 04540217420605
• Version / Model: 228-65202-55
• Company Name: SHIMADZU CORPORATION
• Labeler DUNS: 690558747
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-15
• Public Version: 2
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: bc3c867e-02d3-404d-867d-06a156322ee8

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KIE	Apparatus, High Pressure Liquid Chromatography	Clinical Chemistry	862.2260	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57845	High performance liquid chromatography analyser IVD	An electrically-powered automated or semi-automated laboratory instrument designed for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. Chemical components are separated by passing pressurized liquid through a narrow column to allow the various components to separate based on their chemical/physical properties while interacting with column filling. As the substances exit the column they are detected and identified electronically or spectrometrically. The device is used for the identification of complex substances such as drugs and hormones.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04540217420605	GS1