UNICO

Primary DI
00816668020157
Brand
UNICO
Company
UNITED PRODUCTS & INSTRUMENTS
Model
L-BC9
Published
2020-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GKMHand-Tally, Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKMHand-Tally, DifferentialHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816668020157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816668020157008166680201578166680201570816668020157

GMDN Terms#

Term, Definition table
TermDefinition
Differential white blood cell count recorder IVD, non-poweredA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796269165
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816668020003UNICOCMH30CMH302016-08-23
00816668020010UNICO POWERSPIN BXC882C8822016-08-23
00816668020096UNICO POWERSPIN BXC885C8852017-04-10
00816668020102UNICO POWERSPIN BXC884C8842017-04-21
00816668020027UNICO ColpoMaster ICS-103LEDCS-103LED2016-08-23
00816668020034UNICO ColpoMaster ICS-103T-LEDCS-103T-LED2016-08-23
00816668020041UNICO ColpoMaster ICS-105LEDCS-105LED2016-08-23
00816668020058UNICO ColpoMaster ICS-105T-LEDCS-105T-LED2016-08-23
00816668020065UNICO ColpoMaster IICS-205LEDCS-205LED2016-08-23
00816668020072UNICO ColpoMaster IICS-205T-LEDCS-205T-LED2016-08-23
00816668020089UNICO ColpoMaster IIICS-305CS-3052016-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885632109300MediChoiceOWENS & MINOR DISTRIBUTION, INC.GKM2020-10-06
40612479200140McKessonMCKESSON MEDICAL-SURGICAL INC.GKM2020-05-28
40612479217421McKessonMCKESSON MEDICAL-SURGICAL INC.GKM2020-05-28