Home GUDID 20883489001850 RIGHTEST GT333 Blood Glucose Monitoring System
Primary DI 20883489001850
Brand RIGHTEST GT333 Blood Glucose Monitoring System
Company BIONIME CORPORATION
Model Meter
Published 2019-10-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name NBW System, Test, Blood Glucose, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00883489001856 Package GS1 1 In Commercial Distribution 20883489001850 Package GS1 50 In Commercial Distribution 00883489001849 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 00883489001856 00883489001856 883489001856 0883489001856 20883489001850 20883489001850 00883489001849 00883489001849 883489001849 0883489001849
GMDN Terms# Term, Definition table Term Definition Glucose monitoring system IVD, home-use A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity
Regulatory Flags# DUNS number 658637244 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00682607551354 ON CALL® SURE BLOOD GLUCOSE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607551361 ON CALL® SURE BLOOD GLUCOSE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607551378 ON CALL® SURE BLOOD GLUCOSE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815234 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815241 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815258 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607815265 ON CALL® SURE BLOOD KETONE STRIPS Acon Laboratories, Inc. NBW 2026-07-31 00682607551385 ON CALL® SURE BLOOD CONTROL SOLUTION Acon Laboratories, Inc. NBW 2026-07-30 00682607551392 ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607551408 ON CALL® SURE BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551422 ON CALL® SURE BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551439 ON CALL® SURE BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551446 ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607551453 ON CALL® SURE SYNC BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551460 ON CALL® SURE SYNC BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607551477 ON CALL® SURE SYNC BLOOD GLUCOSE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607815098 ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607815104 ON CALL® SURE GK BLOOD GLUCOSE & KETONE METER Acon Laboratories, Inc. NBW 2026-07-30 00682607815111 ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEM Acon Laboratories, Inc. NBW 2026-07-30 00682607815272 ON CALL® SURE KETONE CONTROL SOLUTION Acon Laboratories, Inc. NBW 2026-07-30 00850078377265 iHealth iHealth Labs Inc. NBW 2026-07-14 00860015091604 KetoBM KETOBM USA LLC NBW 2026-07-14 00860015091611 KetoBM KETOBM USA LLC NBW 2026-07-14 00860015091628 KetoBM KETOBM USA LLC NBW 2026-07-14 00860015091635 KetoBM KETOBM USA LLC NBW 2026-07-14 04719869706904 Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA) TYSON BIORESEARCH INC. NBW 2026-07-13 04719869706911 TysonBio AC500 PRO Blood Glucose Test Strips (50T) TYSON BIORESEARCH INC. NBW 2026-07-13 04719869706928 Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3) TYSON BIORESEARCH INC. NBW 2026-07-13 04719869706942 Tyson Bio AC500 PRO Control Solution (Level 1) (FDA) TYSON BIORESEARCH INC. NBW 2026-07-13 04719869706959 Tyson Bio AC500 PRO Control Solution (Level 3) (FDA) TYSON BIORESEARCH INC. NBW 2026-07-13
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