Home GUDID 00385930000017 UltraTRAK Complete 50 Test Strips
Primary DI 00385930000017
Brand UltraTRAK Complete 50 Test Strips
Company VERTEX DIAGNOSTICS LLC
Model TD-4231
Published 2020-01-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name CGA Glucose Oxidase, Glucose
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CGA Glucose Oxidase, Glucose Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00385930000017 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 00385930000017 00385930000017 385930000017 0385930000017
GMDN Terms# Term, Definition table Term Definition Glucose IVD, kit, electrometry A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).
Regulatory Flags# DUNS number 808107788 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 00385930000000 UltraTRAK TM Complete Blood Glucose Monitoring System TD-4231 2020-01-23 00385930011013 UltraTRAK TM 50 Test Strips TD-4255&TD-4275 2020-01-23 00385930011112 Ultra TRAK TM ULTIMATE TEST STRIP (50 Test Strips) TD-4277 2020-01-23 00385930011020 Ultra TRAK PRO Blood Glucose Monitoring System TD-4255 2020-01-23 00385930011082 UltraTRAK PRO Blood Glucose Monitoring System TD-4255 2020-01-23 00385930011099 UltraTrak TM ULTIMATE Blood Glucose Monitoring System TD-4277 2020-01-23
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00384841518802 Prodigy AutoCode Blood Glucose Monitoring System Prodigy Diabetes Care, LLC CGA 2026-08-13 04719869706904 Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA) TYSON BIORESEARCH INC. CGA 2026-07-13 04719869706911 TysonBio AC500 PRO Blood Glucose Test Strips (50T) TYSON BIORESEARCH INC. CGA 2026-07-13 04719869706942 Tyson Bio AC500 PRO Control Solution (Level 1) (FDA) TYSON BIORESEARCH INC. CGA 2026-07-13 04719869706959 Tyson Bio AC500 PRO Control Solution (Level 3) (FDA) TYSON BIORESEARCH INC. CGA 2026-07-13 05700693930978 ABL90 FLEX Radiometer Medical ApS CGA 2026-07-09 05700693930985 ABL90 FLEX PLUS Radiometer Medical ApS CGA 2026-07-09 05700699446572 SP90 Radiometer Medical ApS CGA 2026-07-09 05700699447579 SP90 Radiometer Medical ApS CGA 2026-07-09 05700699461056 SC90 Radiometer Medical ApS CGA 2026-07-09 05700699461087 SC90 Radiometer Medical ApS CGA 2026-07-09 05700699461094 SC90 Radiometer Medical ApS CGA 2026-07-09 05700699461100 SC90 Radiometer Medical ApS CGA 2026-07-09 05700699461131 SC90 Radiometer Medical ApS CGA 2026-07-09 05700699461605 SC90 Radiometer Medical ApS CGA 2026-07-09 MHC1101665142 EasyTouch MHC MEDICAL PRODUCTS, LLC CGA 2026-01-07 MHC18073002 EasyTouch MHC MEDICAL PRODUCTS, LLC CGA 2026-01-07 00311917064635 Walgreens WALGREEN CO. CGA 2025-06-20 00353885013000 OneTouch Ultra LifeScan U.S. LLC CGA 2025-06-20 00194346219254 ReliOn™ Premier Blood Glucose Test Strips WAL-MART STORES, INC. CGA 2025-02-11 00194346219261 ReliOn™ Premier Blood Glucose Test Strips WAL-MART STORES, INC. CGA 2025-02-11 00054749005710 i-STAT G Cartridge ABBOTT POINT OF CARE INC. CGA 2024-04-30 00381932488013 Assy Vial, eGLU, 13 ct. POLYMER TECHNOLOGY SYSTEMS, INC. CGA 2023-07-30 MHC19902833042 Members Mark WAL-MART STORES, INC. CGA 2023-05-10 MHC19902833062 Members Mark WAL-MART STORES, INC. CGA 2023-04-18 MHC19902833072 Members Mark WAL-MART STORES, INC. CGA 2023-04-18 10385480631645 Nova Primary NOVA BIOMEDICAL CORPORATION CGA 2023-02-24 10385480631652 Nova Primary NOVA BIOMEDICAL CORPORATION CGA 2023-02-24 10385480631669 Nova Primary NOVA BIOMEDICAL CORPORATION CGA 2023-02-24 10385480632307 Nova Primary NOVA BIOMEDICAL CORPORATION CGA 2023-02-22