UNICO

Basic Information

• Brand Name: UNICO
• Primary DI: 00816668020157
• Version / Model: L-BC9
• Company Name: UNITED PRODUCTS & INSTRUMENTS
• Labeler DUNS: 796269165
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-16
• Public Version: 2
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 7059082e-e949-48b2-99b9-e59c5dbc3590

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: Yes
• 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
GKM	Hand-Tally, Differential	Hematology	864.6160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64079	White blood cell differential count recorder IVD, non-powered	A non-powered device intended to be used by a healthcare professional to manually record and display haematological cell counts of white blood cell populations in a clinical specimen, as observed under a microscope. It consists of multiple mechanical tally counters with a lever representing each white blood cell type (e.g., basophil, eosinophil, lympocyte) which the operator depresses to record an observed cell type. Totals for population counts are displayed on the device and used to subsequently calculate the percentages for each population.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816668020157	GS1