Home GUDID 00860010522301 Hemaprep
Primary DI 00860010522301
Brand Hemaprep
Company J P Gilbert Company Inc
Model 756300
Catalog number 756300
Device description Blood smear instrument automated; Microscope slide maker IVD; portable, light weight (1 pound); no external power required.
Published 2023-10-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GKJ Spinner, Slide, Automated
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GKJ Spinner, Slide, Automated Hematology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860010522301 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860010522301 00860010522301 860010522301 0860010522301
GMDN Terms# Term, Definition table Term Definition Microscope slide maker IVD An automated mains electricity (AC-powered) laboratory instrument intended to be used to prepare, transfer and/or fix blood, tissue or other clinical specimens onto microscope examination slides so they are suitable for subsequent staining and/or microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.
Device Sizes# Type, Value, Unit table Type Value Unit Depth 6.3 Inch Height 5.4 Inch Width 3.5 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 no special storage condition for shipment or storage Special Storage Condition, Specify 0 0 none
Regulatory Flags# DUNS number 949182117 Device count 1 Premarket exempt true Serial number true Other Devices Sharing Product Codes#