FDA.reportPublic FDA data

medisana BG 150 Blood Glucose Monitoring System

Primary DI
04719869706973
Brand
medisana BG 150 Blood Glucose Monitoring System
Company
TYSON BIORESEARCH INC.
Model
BG 150
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170079000Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring SystemTyson Bioresearch, Inc.2017-10-06NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719869706970PackageGS140In Commercial Distribution
04719869706973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471986970697014719869706970
04719869706973047198697069734719869706973

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
658026104
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)Tyson Bio AC500 PRO2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)Tyson Bio AC500 PRO2026-07-13
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)Tyson Bio AC500 PRO2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)Tyson Bio AC500 PRO2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)Tyson Bio AC500 PRO2026-07-13
04719869706980medisana BG 150 Blood Glucose Test Strips (50Tx2)BG 1502026-07-13
04719869706997medisana BG 150 Control Solution (Level 2)BG 1502026-07-13
04719869700667EZ Smart-608 Blood Glucose Test Strips (50T)EZ Smart-6082017-09-26
04719869701053TysonBio EVOLVE Blood Glucose Test Strips (25T)TysonBio EVOLVE2017-09-26
04719869701060TysonBio EVOLVE Blood Glucose Test Strips (50T)TysonBio EVOLVE2017-09-26
04719869701824Tyson Bio HT100 Blood Glucose Test Strip , 25THT1002018-07-17
04719869701831Tyson Bio HT100 Blood Glucose Test Strip , 50THT1002018-07-17
04719869701978Tyson Bio HT100-B Blood Glucose Test Strip , 50THT100-B2020-08-11
04719869701985Tyson Bio HT100-B Blood Glucose Test Strip, 25THT100-B2020-08-11
04719869702333Tyson Bio 50H Blood Glucose Test Strip, 25TTyson Bio 50H2019-03-11
04719869702340Tyson Bio 50H Blood Glucose Test Strip, 50TTyson Bio 50H2019-03-11
04719869703118TysonBio AC500 Blood Glucose Test Strips, 50TAC5002020-04-15
04719869703125TysonBio AC500 Blood Glucose Test Strips, 25TAC5002020-04-15
04719869705884Tyson Bio HS100 Blood Glucose Test StripsHS1002024-11-11
04719869705891Tyson Bio HS100 Blood Glucose Test StripsHS100 2024-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04719869706980medisana BG 150 Blood Glucose Test Strips (50Tx2)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706997medisana BG 150 Control Solution (Level 2)TYSON BIORESEARCH INC.NBW2026-07-13
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
06225000563827Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06225000563841Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06225000563865Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06223015680010Be SureEPS BIO TECHNOLOGY CORP.NBW2026-05-07
06225000563858Be Smart Blood Glucose MeterEPS BIO TECHNOLOGY CORP.NBW2026-05-07
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
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20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27
00010939958617TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2023-09-12
00010939958693TRUE METRIXTRIVIDIA HEALTH, INC.NBW2023-09-12
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05