FDA.reportPublic FDA data

Curaplex

Primary DI
00810094575526
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
670263-KIT
Catalog number
670263-KIT
Device description
Curaplex Combo Chest Seal Kit
Published
2023-03-30
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
NAEDressing, wound, hydrogel without drug and/or biologic
OHOFirst aid kit without drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094575526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094575526008100945755268100945755260810094575526

GMDN Terms#

Term, Definition table
TermDefinition
Pneumothorax dressingA sterile covering applied to a chest wound that has penetrated the pleura (serous membrane covering the lungs and lining the pleural cavity) in order to temporarily treat and prevent pneumothorax (collapsed lung). The device may be self-adhesive and have a one-way valve that enables internal pressure release while preventing air entry. It is typically used by first responders [emergency medical services (EMS)] in the management of penetrating chest trauma (e.g., bullet or stab wounds). This is a single-use device.

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
M6898723101040Bleeding Control KitSafeguard US Operating, LLCOHO2026-10-22
M68981601030Rant Strategies K9 Trauma KitSafeguard US Operating, LLCOHO2026-10-20
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
00842209140480NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140497NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140510NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140565NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140572NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
00842209140589NARNORTH AMERICAN RESCUE, LLCOHO2026-10-14
M689HHCWS01040Compact Wound Seal KitSafeguard US Operating, LLCNAE2026-10-13
M689TOCSEA030Curaplex TOCSSafeguard US Operating, LLCNAE2026-10-13
00810226442917Vive BreatheVIVE HEALTH LLCNAE2026-10-12
00743537001118BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-10-05
00743537001224BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-10-05
00743537001231BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-10-05
00199972000801CuraplexBOUND TREE MEDICAL, LLCOHO2026-09-30
00199972000825CuraplexBOUND TREE MEDICAL, LLCOHO2026-09-30
00199972000849CuraplexBOUND TREE MEDICAL, LLCOHO2026-09-30
00199972000863CuraplexBOUND TREE MEDICAL, LLCOHO2026-09-30
00199972000887CuraplexBOUND TREE MEDICAL, LLCOHO2026-09-30
00199972000900CuraplexBOUND TREE MEDICAL, LLCOHO2026-09-30