FDA.reportPublic FDA data

Tenovi

Primary DI
00860008115911
Brand
Tenovi
Company
Tenovi Co.
Model
TE-STR-A1
Device description
Glucometer Test Strips (50 Pack)
Published
2022-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008115911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008115911008600081159118600081159110860008115911

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
127061577
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850068074204TenoviTE-CBPS-B12026-04-14
00850068074563TenoviTE-BBPH-B12026-04-14
00850068074082TenoviTE-CPOG-A12026-01-14
00860008115997TenoviTE-BBPL-A12026-01-14
00850068074105TenoviTE-BPOG-A12026-01-07
00850068074402TenoviTE-BBPL-C12026-01-05
00850068074174TenoviTE-KBGZ-A12026-01-02
00850068074181TenoviTE-CBPL-B12026-01-02
00850068074211TenoviTE-CBPH-B12026-01-02
00850068074228TenoviTE-KPBG-A22026-01-02
00850068074266TenoviTE-CBGZ-A12026-01-02
00850068074365TenoviTE-BBPS-B12026-01-02
00850068074518TenoviTE-BFDG-A12025-11-24
00850068074310TenoviTE-BSCW-A12025-11-20
00850068074389TenoviTE-CSCW-A12025-11-20
00850068074457TenoviTE-BBGZ-B12025-11-20
00850068074471TenoviTE-BSCR-B12025-11-20
00085006807402TenoviTE-BPBG-A12025-08-29
00850068074020TenoviTE-BPBG-A12025-09-08
00850068074006TenoviTE-BTMI-A12025-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04719869706973medisana BG 150 Blood Glucose Monitoring SystemTYSON 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
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
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