Home GUDID 14719869703108 Tyson Bio AC500 Blood Glucose Monitoring System
Primary DI 14719869703108
Brand Tyson Bio AC500 Blood Glucose Monitoring System
Company TYSON BIORESEARCH INC.
Model AC500
Published 2020-04-15
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 true 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 14719869703108 Package GS1 80 In Commercial Distribution 24719869703105 Package GS1 72 In Commercial Distribution 04719869703101 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14719869703108 14719869703108 24719869703105 24719869703105 04719869703101 04719869703101 4719869703101
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.
Regulatory Flags# DUNS number 658026104 Device count 1 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04719869706904 Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA) Tyson Bio AC500 PRO 2026-07-13 04719869706911 TysonBio AC500 PRO Blood Glucose Test Strips (50T) Tyson Bio AC500 PRO 2026-07-13 04719869706928 Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3) Tyson Bio AC500 PRO 2026-07-13 04719869706942 Tyson Bio AC500 PRO Control Solution (Level 1) (FDA) Tyson Bio AC500 PRO 2026-07-13 04719869706959 Tyson Bio AC500 PRO Control Solution (Level 3) (FDA) Tyson Bio AC500 PRO 2026-07-13 04719869706973 medisana BG 150 Blood Glucose Monitoring System BG 150 2026-07-13 04719869706980 medisana BG 150 Blood Glucose Test Strips (50Tx2) BG 150 2026-07-13 04719869706997 medisana BG 150 Control Solution (Level 2) BG 150 2026-07-13 04719869700667 EZ Smart-608 Blood Glucose Test Strips (50T) EZ Smart-608 2017-09-26 04719869701053 TysonBio EVOLVE Blood Glucose Test Strips (25T) TysonBio EVOLVE 2017-09-26 04719869701060 TysonBio EVOLVE Blood Glucose Test Strips (50T) TysonBio EVOLVE 2017-09-26 04719869701824 Tyson Bio HT100 Blood Glucose Test Strip , 25T HT100 2018-07-17 04719869701831 Tyson Bio HT100 Blood Glucose Test Strip , 50T HT100 2018-07-17 04719869701978 Tyson Bio HT100-B Blood Glucose Test Strip , 50T HT100-B 2020-08-11 04719869701985 Tyson Bio HT100-B Blood Glucose Test Strip, 25T HT100-B 2020-08-11 04719869702333 Tyson Bio 50H Blood Glucose Test Strip, 25T Tyson Bio 50H 2019-03-11 04719869702340 Tyson Bio 50H Blood Glucose Test Strip, 50T Tyson Bio 50H 2019-03-11 04719869703118 TysonBio AC500 Blood Glucose Test Strips, 50T AC500 2020-04-15 04719869703125 TysonBio AC500 Blood Glucose Test Strips, 25T AC500 2020-04-15 04719869705884 Tyson Bio HS100 Blood Glucose Test Strips HS100 2024-11-11
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