FDA.reportPublic FDA data

BEWELL CONNECT MyGluco

Primary DI
03760165449225
Brand
BEWELL CONNECT MyGluco
Company
VISIOMED GROUP
Model
BW-GL1
Published
2017-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760165449225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760165449225037601654492253760165449225

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA 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
261118805
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760165449232BEWELL CONNECT MyGluco Test StripBW-STGL12017-05-12
03760165448167BEWELL CONNECT MyOxyBW-OX12017-04-28
03700609705098THERMOFLASHLX-26E VINYL BLEU2017-04-28
03700609705104THERMOFLASHLX-26E VINYL GREEN2017-04-28
03700609705111THERMOFLASHLX-26E VINYL PINK2017-04-28
03700609705128THERMOFLASHLX-26E POP PINK2017-04-28
03700609705135THERMOFLASHLX-26E POP BLUE2017-04-28
03700609705142THERMOFLASHLX-26E POP GREEN2017-04-28
03760165440291BEWELL CONNECT MyThermoBW-CX102017-04-28
03760165446408THERMOFLASHLX-361T2017-04-28
03760165447429THERMOFLASHLX-26E WHITE2017-04-28
03760165447467THERMOFLASHLX-26E TONIC BLUE2017-04-28
03760165447474THERMOFLASHLX-26E TONIC MAGENTA2017-04-28
03760165447481THERMOFLASHLX-26E TONIC ANIS2017-04-28
03760165448242THERMOFLASHLX-260TE 2017-04-28
03760165448259THERMOFLASHLX-261E2017-04-28
03760165449478THERMOFLASHLX-26E OCEAN BLUE2017-04-28
03760165449485THERMOFLASHLX-26E LIGHT BLUE2017-04-28
03760165449492THERMOFLASHLX-26E GREEN2017-04-28
03760165449836THERMOFLASHLX-26E PINK2017-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
MHC1101665142EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
MHC18073002EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
00311917064635WalgreensWALGREEN CO.CGA2025-06-20
00353885013000OneTouch UltraLifeScan U.S. LLCCGA2025-06-20
00194346219254ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00194346219261ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00383568100826CareLiving BGM101 Blood Glucose MeterCare Living Diagnostics Inc.CGA2024-08-07
00384840105003Prodigy No Coding Blood Glucose Test StripsProdigy Diabetes Care, LLCCGA2024-07-11
00384840104006Prodigy No Coding Blood Glucose Test StripsProdigy Diabetes Care, LLCCGA2024-07-10
00054749005710i-STAT G CartridgeABBOTT POINT OF CARE INC.CGA2024-04-30
00383568100734CareLiving MM1100 Blood Glucose Test Strips 100ctCare Living Diagnostics Inc.CGA2024-04-19
00383568100741CareLiving MM1100 Blood Glucose Test Strips 50ct Care Living Diagnostics Inc.CGA2024-04-19
00383568100819CareLiving Blood Glucose Test Strips 100ctCare Living Diagnostics Inc.CGA2023-11-15
00383568100857CareLiving Blood Glucose Test Strips 50ct Care Living Diagnostics Inc.CGA2023-11-15
00383568100710CareLiving MM1100 Blood Glucose Monitoring SystemCare Living Diagnostics Inc.CGA2023-11-14
00381932488013Assy Vial, eGLU, 13 ct.POLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-07-30
00381934755014eGLU, 15ct., CCPlus HomePOLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-06-20
00381934752013Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk)POLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-06-01
MHC19902833042Members MarkWAL-MART STORES, INC.CGA2023-05-10
MHC19902833062Members MarkWAL-MART STORES, INC.CGA2023-04-18
MHC19902833072Members MarkWAL-MART STORES, INC.CGA2023-04-18
00381934748016Assy Vial, eGLU Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-03-25
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
00353885012652OneTouch Ultra Blue Test StripsLifeScan U.S. LLCCGA2022-07-28
00381934750019CardioChek Plus Home Self-Test AnalyzerPOLYMER TECHNOLOGY SYSTEMS, INC.CGA2022-04-11
MHC18490502BluLinkMHC MEDICAL PRODUCTS, LLCCGA2021-05-12