FDA.reportPublic FDA data

Curaplex

Primary DI
00812277036824
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
670206-KIT
Catalog number
670206-KIT
Device description
Curaplex JFAK with SOFTT TQ
Published
2020-11-30
Public version status
New
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
GAXTOURNIQUET, NONPNEUMATIC
OHOFirst aid kit without drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812277036824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812277036824008122770368248122770368240812277036824

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
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
00810094575809Curaplex680152-KIT680152-KIT2023-04-30
00815277028059Curaplex8600-ATFMLOK2016-12-14
00815277029377Curaplex680150-KIT680150-KIT2018-12-15
01999720000003Curaplex Advanced Hemostatic Gauze4in x 4in(10cm x 10cm)CAHG-4X42025-11-25
01999720000027Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-11-25
01999720000041Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-11-25
01999720000065Curaplex®8600-015558600-015552025-11-13
01999720000263Curaplex670070-KIT670070-KIT2025-11-25
00810071638619CURAPLEXS1137301-S11372023-03-30
00817617023052Curaplex3141-910103141-910102017-09-04
00817617023069Curaplex3141-910123141-910122017-09-04
00817617023083Curaplex3141-910143141-910142017-09-04
00817617023335Curaplex36111361112017-09-04
00199972000085Curaplex8600-015358600-015352026-01-23
00199972000092Curaplex8600-015368600-015362026-01-23
00199972000108Curaplex8600-015378600-015372026-01-23
00199972000115Curaplex8600-015388600-015382026-01-23
00199972000122Curaplex8600-015398600-015392026-01-23
00199972000139Curaplex8600-015408600-015402026-01-23
00199972000146Curaplex8600-015418600-015412026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842209138760NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138777NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138784NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138791NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138807NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138814NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138821NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138838NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138845NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138852NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138869NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138876NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138883NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138937NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138968NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
00842209138975NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27
M6898444601190Mojo Multi Mission - AdvancedSafeguard US Operating, LLCOHO2026-05-27
20888277414249MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-20
50842209110662NARNORTH AMERICAN RESCUE, LLCOHO2026-05-11
20888277717388MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196774662MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196781462MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
M6898130301130MARCH IFAK RESUPPLYSafeguard US Operating, LLCOHO2026-05-05
M6898141003030Maritime First Aid Resupply - AdvancedSafeguard US Operating, LLCOHO2026-04-07
M689WJBBC4010Bleeding Control Kit Plus 6/cs Safeguard US Operating, LLCOHO2026-04-02
M6898113201100Mojo IFAK - BasicSafeguard US Operating, LLCOHO2026-02-19
M68983323100Mojo Combat Lifesaver Bag - IntermediateSafeguard US Operating, LLCOHO2025-10-27
M689SHTPKSM040Trauma PackSafeguard US Operating, LLCOHO2025-10-16
M689SHTPKTMTSM040TRAUMA BLEED CONTROL INDIV.Safeguard US Operating, LLCOHO2025-10-16
M68984497110Mojo Direct Action - AdvancedSafeguard US Operating, LLCOHO2025-04-10