CA CAL S

Basic Information

• Brand Name: CA CAL S
• Primary DI: 04987562516797
• Version / Model: 014-1271-4
• Company Name: SYSMEX CORPORATION
• Labeler DUNS: 690664461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2024-02-22
• Public Version: 1
• Public Version Date: 2024-03-01
• Public Version Status: New
• Public Device Record Key: 81660a48-b600-40b5-aa9f-1092f13da01e

Device Description

The product is applied to calibrate the sensitivity of LEDs used for blood coagulation analyzer.

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: 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
GKP	INSTRUMENT, COAGULATION, AUTOMATED	Hematology	864.5400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55995	Multiple coagulation factor IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	14987562516794	GS1
Primary	04987562516797	GS1

Customer Contacts

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