Curaplex

Primary DI
00812277036411
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01458
Catalog number
8600-01458
Device description
*Custom* Phx Glucose Check Kit
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CFWCOPPER REDUCTION, GLUCOSE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFWCopper Reduction, GlucoseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812277036411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812277036411008122770364118122770364110812277036411

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810094574826Curaplex301-PrO2LTEZ-MM301-PrO2LTEZ-MM2023-04-10
00810094574833Curaplex301-PrO2LTEZ-MSA301-PrO2LTEZ-MSA2023-04-10
00810094574840Curaplex301-PrO2LTEZ301-PrO2LTEZ2023-04-10
00810094574857Curaplex301-PrO2LT-FM301-PrO2LT-FM2023-04-10
00810094574864Curaplex301-PrO2LT-0301-PrO2LT-02023-04-10
00810094574871Curaplex301-PrO2LTEZ-MF301-PrO2LTEZ-MF2023-04-10
00810094573072Curaplex301-44F10-120301-44F10-1202022-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810071631986CuraplexBOUND TREE MEDICAL, LLCCFW2021-09-30
00812277036404CuraplexBOUND TREE MEDICAL, LLCCFW2020-04-30
00815277029827CuraplexBOUND TREE MEDICAL, LLCCFW2018-12-15
00815277029834CuraplexBOUND TREE MEDICAL, LLCCFW2018-12-15
00815277029841CuraplexBOUND TREE MEDICAL, LLCCFW2018-12-15
00815277022835CuraplexBOUND TREE MEDICAL, LLCCFW2016-12-14
00815277027960CuraplexBOUND TREE MEDICAL, LLCCFW2016-12-14
00815277028028CuraplexBOUND TREE MEDICAL, LLCCFW2016-12-14
00817617020426CuraplexBOUND TREE MEDICAL, LLCCFW2016-12-14