FDA.reportPublic FDA data

Eocene

Primary DI
00854067005221
Brand
Eocene
Company
VALUE PROVIDERS LLC
Model
EHS-SDCS-N
Device description
Smart Diabetes Control Solution
Published
2018-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
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
00854067005221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854067005221008540670052218540670052210854067005221

GMDN Terms#

Term, Definition table
TermDefinition
Blood glucose/blood pressure monitoring system, home-useA collection of devices intended for the quantitative measurement of glucose levels in whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure; 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. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079213227
Device count
1
Premarket exempt
true
Combination product
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854067005238Smart DiabetesEHS-SDMK-V2022-01-19
00854067005252EoceneEOC-SBPBT-L2018-04-02
00854067005276EoceneEHS-SDTH2018-04-02
00854067005191EoceneEHS-SDMK-BT2018-04-02
00854067005269EoceneEHS-SDWS2018-04-02
00854067005207EoceneEHS-SDTS-502018-04-02

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.CGA2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
05700693930978ABL90 FLEXRadiometer Medical ApSCGA2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGA2026-07-09
05700699446572SP90Radiometer Medical ApSCGA2026-07-09
05700699447579SP90Radiometer Medical ApSCGA2026-07-09
05700699461056SC90Radiometer Medical ApSCGA2026-07-09
05700699461087SC90Radiometer Medical ApSCGA2026-07-09
05700699461094SC90Radiometer Medical ApSCGA2026-07-09
05700699461100SC90Radiometer Medical ApSCGA2026-07-09
05700699461131SC90Radiometer Medical ApSCGA2026-07-09
05700699461605SC90Radiometer Medical ApSCGA2026-07-09
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