FDA.reportPublic FDA data

Curaplex

Primary DI
00815277027724
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
660488
Device description
Curaplex Med-E-Pack 3 - Refill Pak
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXQblood pressure cuff
KYPSnake Bite Suction Kit
MCYWound dressing kit
OHOFirst aid kit without drug
OJJBurn kit without drug
OJSTourniquet kit
OKONegative pressure wound therapy non-powered suction apparatus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2
KYPSnake Bite Suction KitGeneral Hospital1
MCYWound Dressing KitGeneral Hospital2
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1
OJJBurn Kit Without DrugGeneral, Plastic Surgery1
OJSTourniquet KitGeneral, Plastic Surgery1
OKONegative Pressure Wound Therapy Non-Powered Suction ApparatusGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277027724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277027724008152770277248152770277240815277027724

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, reusableA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094574765Curaplex301-670249-KIT301-670249-KIT2022-12-08
00810094576950CuraplexSIVSTTCHP-24-KITSIVSTTCHP-24-KIT2024-09-30
00810094576967CuraplexSIVSTGAHP-24-KITSIVSTGAHP-24-KIT2024-09-30
00810094576974CuraplexSIVSTTAHP-24-KITSIVSTTAHP-24-KIT2024-09-30
00810094577049Curaplex1840-012QM1840-012QM2024-09-30
00810094577056Curaplex1840-013QM1840-013QM2024-09-30
00810094577070Curaplex1840-010QM1840-010QM2024-09-30
00810094577087Curaplex1840-011QM1840-011QM2024-09-30
00810094577094Curaplex1840-014QM1840-014QM2024-09-30
00810094575960Curaplex8600-015138600-015132023-06-30
00810094575977Curaplex670268-KIT670268-KIT2023-06-30
00810094575984Curaplex8600-015148600-015142023-06-30
00812277035407Curaplex8600-014088600-014082019-08-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942509220593OP - First aid seriesdata:image/svg+xml,%3csvg%20xmlns='http://www.w3.org/2000/Yiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
06942509220609OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
06942509220616OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
06942509220623OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-24
00850070635226Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635257Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635264Pro Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635288Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635295Response Plus kitNar Medical Depot, LLCOHO2026-10-23
00850070635318Pro Response KitNar Medical Depot, LLCOHO2026-10-23
00850070635356RESPONSE KITNar Medical Depot, LLCOHO2026-10-23
06942509220647OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220708OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220715OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220722OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509220890OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
06942509221217OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.OHO2026-10-23
M6898723101040Bleeding Control KitSafeguard US Operating, LLCOHO2026-10-22
M68981601030Rant Strategies K9 Trauma KitSafeguard US Operating, LLCOHO2026-10-20
00634782102524Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-10-16
00842209140367NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140374NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140398NAR KitNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140404NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140411NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140428NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140435NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140442NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140466NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140473NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14