FDA.reportPublic FDA data

BEWELL CONNECT MyTens

Primary DI
03760165440376
Brand
BEWELL CONNECT MyTens
Company
VISIOMED GROUP
Model
BW-DGM1
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
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760165440376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760165440376037601654403763760165440376

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, point-of-careA collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. 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
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00850078377265iHealthiHealth Labs Inc.NBW2026-07-14
00860015091604KetoBMKETOBM USA LLCNBW2026-07-14
00860015091611KetoBMKETOBM USA LLCNBW2026-07-14
00860015091628KetoBMKETOBM USA LLCNBW2026-07-14
00860015091635KetoBMKETOBM USA LLCNBW2026-07-14
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13