Home GUDID 00096295129229 LEADER
Primary DI 00096295129229
Brand LEADER
Company CARDINAL HEALTH, INC.
Model 5277181
Catalog number 5277181
Device description LDR Blood Glucose Monitoring System
Published 2017-04-26
Public version status Update
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 JJX Single (Specified) Analyte Controls (Assayed And Unassayed) NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry 1 NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00096295129229 Direct Marking GS1 0 30096295129145 Package GS1 4 In Commercial Distribution 30096295134415 Package GS1 4 In Commercial Distribution 50096295129149 Package GS1 6 In Commercial Distribution 50096295134419 Package GS1 6 In Commercial Distribution 00096295129144 Primary GS1 0 00096295134414 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 00096295129229 00096295129229 096295129229 0096295129229 30096295129145 30096295129145 30096295134415 30096295134415 50096295129149 50096295129149 50096295134419 50096295134419 00096295129144 00096295129144 096295129144 0096295129144 00096295134414 00096295134414 096295134414 0096295134414
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 Storage Environment Temperature 5 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 097537435 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true 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 00850075956777 Refractrol SP Normal Lgc Clinical Diagnostics, Inc. JJX 2026-07-30 00850075956784 Refractrol SP 9.0 High Lgc Clinical Diagnostics, Inc. JJX 2026-07-30 00850075956807 Refractrol SP High Lgc Clinical Diagnostics, Inc. JJX 2026-07-30 00850075957286 Refractrol SP Low Lgc Clinical Diagnostics, Inc. JJX 2026-07-30 00850075956791 Refractrol SP 6.0 Low Lgc Clinical Diagnostics, Inc. JJX 2026-07-28 10758750035847 VITROS ORTHO CLINICAL DIAGNOSTICS JJX 2026-07-21 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
xxx.xxx