Home GUDID 40301937283350 CONTOUR® NEXT
Primary DI 40301937283350
Brand CONTOUR® NEXT
Company ASCENSIA DIABETES CARE US INC.
Model 7283
Catalog number 7283
Device description Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
Published 2016-09-16
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name OZO Artificial Pancreas Device System, Threshold Suspend
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OZO Automated Insulin Dosing , Threshold Suspend Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 40301937283350 Package GS1 12 Not in Commercial Distribution 00301937283352 Primary GS1 0 0193-7283-35 Secondary NDC/NHRIC 0 00301937283017 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 40301937283350 40301937283350 00301937283352 00301937283352 301937283352 0301937283352 00301937283017 00301937283017 301937283017 0301937283017
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 Special Storage Condition, Specify 0 0 Store test strips in their original bottle only. Always close the lid immediately and tightly after removing a test strip. Do not use after expiration date. Storage Environment Humidity 10 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature 41 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 080028910 Device count 35 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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 00643169455535 ENLiTE™ MEDTRONIC MINIMED, INC. OZO 2023-07-20 00643169873834 MiniMed® 630G MEDTRONIC MINIMED, INC. OZO 2018-02-05 00643169932999 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-11-30 00643169933002 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-11-30 00643169933019 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-11-30 00643169933026 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-11-30 00643169933033 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-11-30 00643169786738 Enlite ® MEDTRONIC MINIMED, INC. OZO 2017-11-25 00643169736030 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736047 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736078 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736320 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736337 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736344 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736351 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736368 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736375 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736382 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736399 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736405 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736412 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736429 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736436 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736443 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736450 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736467 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736474 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736481 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736498 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-06-01 00643169736061 MiniMed® 530G MEDTRONIC MINIMED, INC. OZO 2017-05-25
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