FDA.reportPublic FDA data

BEWELL CONNECT MyGluco Test Strip

Primary DI
03760165449232
Brand
BEWELL CONNECT MyGluco Test Strip
Company
VISIOMED GROUP
Model
BW-STGL1
Published
2017-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760165449232PrimaryGS10
37601654492490Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760165449232037601654492323760165449232
3760165449249037601654492490

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA 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
261118805
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
03760165449843THERMOFLASHLX-26E ARTIC LIME 2017-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSJJX2022-08-09
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164489uTASWako DCP Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164496uTASWako DCP Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
00021292008390TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00021292008406TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00021292008413TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00353885011969OneTouch Verio Control SolutionLifeScan Europe GmbHJJX2020-10-14
08718734960584Eurotrol GlucoTrol-NG Eurotrol B.V.JJX2020-10-08
08718734960607Eurotrol GlucoTrol-NG Eurotrol B.V.JJX2020-10-08