Home GUDID 00812277036404 Curaplex
Primary DI 00812277036404
Brand Curaplex
Company BOUND TREE MEDICAL, LLC
Model 670162-KIT-DOD
Catalog number 670162-KIT-DOD
Device description Assure Prism Orange Kit ADVANCED
Published 2020-04-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name CFW COPPER REDUCTION, GLUCOSE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CFW Copper Reduction, Glucose Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812277036404 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 00812277036404 00812277036404 812277036404 0812277036404
GMDN Terms# Term, Definition table Term Definition Glucose monitoring system IVD, point-of-care A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
Regulatory Flags# DUNS number 070556204 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810071631986 Curaplex BOUND TREE MEDICAL, LLC CFW 2021-09-30 00812277036411 Curaplex BOUND TREE MEDICAL, LLC CFW 2020-04-30 00815277029827 Curaplex BOUND TREE MEDICAL, LLC CFW 2018-12-15 00815277029834 Curaplex BOUND TREE MEDICAL, LLC CFW 2018-12-15 00815277029841 Curaplex BOUND TREE MEDICAL, LLC CFW 2018-12-15 00815277022835 Curaplex BOUND TREE MEDICAL, LLC CFW 2016-12-14 00815277027960 Curaplex BOUND TREE MEDICAL, LLC CFW 2016-12-14 00815277028028 Curaplex BOUND TREE MEDICAL, LLC CFW 2016-12-14 00817617020426 Curaplex BOUND TREE MEDICAL, LLC CFW 2016-12-14