FDA.reportPublic FDA data

Curaplex

Primary DI
00812277030037
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
2763-32703
Catalog number
2763-32703
Device description
Curaplex Blood Glucose Test Strips 50/BX
Published
2018-12-15
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
CGAGLUCOSE OXIDASE, GLUCOSE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082965000DS-A BLOOD GLUCOSE MONITORING SYSTEMAlliance International Co., Ltd.2009-12-07CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812277030044PackageGS12In Commercial Distribution
00812277030051PackageGS1270In Commercial Distribution
00812277030037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812277030044008122770300448122770300440812277030044
00812277030051008122770300518122770300510812277030051
00812277030037008122770300378122770300370812277030037

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY; KEEP AWAY FROM DIRECT SUNLIGHT
Storage Environment Temperature4 Degrees Celsius32 Degrees Celsius

Regulatory Flags#

DUNS number
070556204
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815277027243Curaplex533-MS-25058EA2016-12-16
00817617022758Curaplex533-MS-25058EA2017-02-06
00817617022918Curaplex533-MS-25058EA533-MS-25058EA2017-09-04
00817617022925Curaplex301-181EA301-181EA2017-12-22
00817617022949Curaplex301-180EA301-180EA2017-09-04
00815277025447Curaplex301-181EA2016-12-14
00815277027250Curaplex533-MS-25060EA2016-12-14
00810071630972Curaplex301-101EA301-101EA2022-12-30
00817617022888Curaplex301-107EA301-107EA2017-09-13
00817617022895Curaplex301-100EA301-100EA2017-09-13
00810071638688Curaplex301-FO-MIL-000301-FO-MIL-0002026-10-21
00199972000641Curaplex1015-471711015-471712026-10-15
00199972000672Curaplex1015-471721015-471722026-10-15
00199972000702Curaplex1015-471731015-471732026-10-15
00199972000733Curaplex1015-471741015-471742026-10-15
00199972000764Curaplex1015-471751015-471752026-10-15
00810094576615CuraplexSRxOD2SY-24-KITSRxOD2SY-24-KIT2024-03-30
00817617027630Curaplex1124-324001124-324002023-03-30
00810094574802Curaplex301-PrO2LT301-PrO2LT2023-04-10
00810094574819Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2023-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCCGA2026-08-13
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
00054749005710i-STAT G CartridgeABBOTT POINT OF CARE INC.CGA2024-04-30
MHC19902833042Members MarkWAL-MART STORES, INC.CGA2023-05-10
MHC19902833062Members MarkWAL-MART STORES, INC.CGA2023-04-18
MHC19902833072Members MarkWAL-MART STORES, INC.CGA2023-04-18
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09