Home GUDID 20353885008857 OneTouch Ultra2
Primary DI 20353885008857
Brand OneTouch Ultra2
Company LifeScan Europe GmbH
Model 021-100
Catalog number 021-100
Device description OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
Published 2017-09-13
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 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 20353885008857 Package GS1 10 In Commercial Distribution 00353885008853 Primary GS1 0 53885-452-10 Secondary NDC/NHRIC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20353885008857 20353885008857 00353885008853 00353885008853 353885008853 0353885008853
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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Needle Gauge 30 Gauge
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature 43 Degrees Fahrenheit 111 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Do not refrigerate Special Storage Condition, Specify 0 0 Operating Altitude up to 10000 Feet Storage Environment Temperature 0 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 480240820 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 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 00381934748016 Assy Vial, eGLU Test Strips, 15 ct, CardioChek Plus Home POLYMER TECHNOLOGY SYSTEMS, INC. CGA 2023-03-25 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
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