Home GUDID 04015630946365 Accutrend Plus Meter Kit
Primary DI 04015630946365
Brand Accutrend Plus Meter Kit
Company Roche Diagnostics GmbH
Model 07769202001
Catalog number 07769202001
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
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 04015630946365 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04015630946365 04015630946365 4015630946365
GMDN Terms# Term, Definition table Term Definition Point-of-care blood glucose monitoring system An assembly of devices intended to be operated by a healthcare professional to continually measure patient blood glucose at the point-of-care in a healthcare facility. It is continuously connected to the patient during use and typically consists of a line-powered control unit, with user interface and rechargeable battery, containing a spectrometer to quantitatively measure glucose concentration in received plasma samples; a sterile, single-use cartridge connected to the patient via a venous catheter designed to withdraw a blood sample at intervals, convert it to plasma, and transport it to the control unit for analysis; a heparin syringe; and a sterile cap to protect the patient connector.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -25 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 315028860 Device count 1 Kit true Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07613336223321 Kidney KFRE Algorithm 09891986001 09891986001 2025-03-31 07613336234457 PreciControl Syphilis 09465022190 09465022190 2026-05-15 04015630913893 AMYP Amylase EPS Pancreatic 20766623322 20766623322 2016-09-20 04015630910991 alpha-Amylase liquid acc. to IFCC 11876473316 11876473316 2016-09-20 04015630911004 Pancreatic alpha-amylase liquid 11876562316 11876562316 2016-09-20 04015630926848 alpha-Amylase EPS Pancreatic 5401771190 5401771190 2016-09-20 07613336121016 a-Amylase EPS Pancreatic 08056820190 08056820190 2020-03-05 07613336171509 Elecsys Calcitonin 09005676190 09005676190 2026-06-01 07613336171516 CalSet Calcitonin 09005684190 09005684190 2026-06-01 07613336188064 Elecsys Calcitonin 09005668160 09005668160 2026-06-01 07613336217641 Elecsys Anti-TSHR 09744819190 09744819190 2026-06-01 07613336218341 Elecsys CA 19-9 09755608190 09755608190 2026-06-01 07613336218389 Elecsys Estradiol III 09755659190 09755659190 2026-06-01 07613336235546 PreciControl HIV Gen II 09465006160 09465006160 2026-05-22 07613336231432 Tina-quant Antistreptolysin-O II 09537368190 09537368190 2026-05-08 07613336231449 Tina-quant Antistreptolysin-O II 09537341190 09537341190 2026-05-08 07613336154342 Elecsys Anti-HBc IgM 11820567160 11820567160 2017-09-29 07613336217832 Elecsys Testosterone II 09745963190 09745963190 2026-04-21 07613336153932 Elecsys Anti-HBc IgM 07026811160 07026811160 2018-03-19 00875197004748 cobas® HBV/HCV/HIV-1 Control Kit 1.0 06998887190 2015-12-04
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 00383568100826 CareLiving BGM101 Blood Glucose Meter Care Living Diagnostics Inc. CGA 2024-08-07 00384840105003 Prodigy No Coding Blood Glucose Test Strips Prodigy Diabetes Care, LLC CGA 2024-07-11 00384840104006 Prodigy No Coding Blood Glucose Test Strips Prodigy Diabetes Care, LLC CGA 2024-07-10 00054749005710 i-STAT G Cartridge ABBOTT POINT OF CARE INC. CGA 2024-04-30 00383568100734 CareLiving MM1100 Blood Glucose Test Strips 100ct Care Living Diagnostics Inc. CGA 2024-04-19 00383568100741 CareLiving MM1100 Blood Glucose Test Strips 50ct Care Living Diagnostics Inc. CGA 2024-04-19 00383568100819 CareLiving Blood Glucose Test Strips 100ct Care Living Diagnostics Inc. CGA 2023-11-15 00383568100857 CareLiving Blood Glucose Test Strips 50ct Care Living Diagnostics Inc. CGA 2023-11-15 00383568100710 CareLiving MM1100 Blood Glucose Monitoring System Care Living Diagnostics Inc. CGA 2023-11-14 00381932488013 Assy Vial, eGLU, 13 ct. POLYMER TECHNOLOGY SYSTEMS, INC. CGA 2023-07-30