Ricca Chemical Company®

Basic Information

• Brand Name: Ricca Chemical Company®
• Primary DI: 00192024036179
• Version / Model: 3500-32
• Catalog Number: 3500
• Company Name: Ricca Chemical Company, LLC
• Labeler DUNS: 020335667
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-04
• Public Version: 1
• Public Version Date: 2021-02-12
• Public Version Status: New
• Public Device Record Key: f1b008a9-abb3-4aed-84e9-87441cf2f342

Device Description

Hayem Diluting Fluid, for Erythrocyte (Red Cell) Count

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: Yes
• 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
GJN	FLUID, DILUTING, RED-CELL	Hematology	864.8200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55857	Red blood cell count IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of red blood cells (erythrocytes) and/or the calculation of intermediate red cell parameters in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192024036179	GS1

Customer Contacts

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