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
00810071637285Curaplex301-P3050301-P3050EA2022-12-30
00810071637292CuraplexP3052EA301-P3052EA2022-12-30
00810071637308Curaplex301-P3054301-P3054EA2022-12-30
00199972000436Curaplex8600-01565-KIT8600-01565-KIT2026-08-15
00199972000443Curaplex670283-KIT670283-KIT2026-08-15
00199972000450Curaplex670284-KIT670284-KIT2026-08-15
00199972000467Curaplex8600-01567-KIT8600-01567-KIT2026-08-15
00199972000474Curaplex8600-01558-KIT8600-01558-KIT2026-08-15
00199972000528CuraplexSIVBDIO02-26-KITSIVBDIO02-26-KIT2026-08-15
00199972000535Curaplex670289-KIT670289-KIT2026-08-15
00199972000559Curaplex670290-KIT670290-KIT2026-08-15
00199972000573Curaplex670291-KIT670291-KIT2026-08-15
00810094578053Curaplex®SIVBDIO01-24-KITSIVBDIO01-24-KIT2026-07-30
00199972000504Curaplex8600-015668600-015662026-07-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841277111248Novera BalanceHarps USA, Inc.NAE2026-09-04
00850062467224TC3 CLS Kit, CBAltitude Technologies Inc.OHO2026-08-27
M68981129060Mojo Patrol IFAK IISafeguard US Operating, LLCOHO2026-08-26
M689SDREDC1OTC050SDR-EDC1-OTCSafeguard US Operating, LLCOHO2026-08-26
M689SDRTBBOTC060SDR Tactical Battle Belt IFAK-OTCSafeguard US Operating, LLCOHO2026-08-26
M68981139010LEO Patrol KitSafeguard US Operating, LLCOHO2026-08-25
M68981301030MARCH IFAK RefillSafeguard US Operating, LLCOHO2026-08-25
M6898130330010MARCH IFAK RESUPPLY Cs of 30Safeguard US Operating, LLCOHO2026-08-25
M68981605020K9 Trauma KitSafeguard US Operating, LLCOHO2026-08-25
M68987155030TX Bleeding Control Kit - AdvancedSafeguard US Operating, LLCOHO2026-08-25
M68987232010Stop the Bleed Kit (NJSP)Safeguard US Operating, LLCOHO2026-08-25
M689SDREDC1OTC010SDR-EDC1OTCSafeguard US Operating, LLCOHO2026-08-25
M689SDRTBBOTC020SDR Tactical Battle Belt IFAK-OTCSafeguard US Operating, LLCOHO2026-08-25
00842209139620NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139637NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139644NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139651NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139668NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139675NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139705NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139750NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139811NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139828NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139835NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139842NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00199972000443CuraplexBOUND TREE MEDICAL, LLCOHO2026-08-15
00199972000450CuraplexBOUND TREE MEDICAL, LLCOHO2026-08-15
08809319802631HyFer HerNonMOON-X USA, Inc.NAE2026-08-03
00850056748742Pacific BiomedicalINTEGRATED MEDCRAFT LLCOHO2026-07-31
00850056748735Pacific BiomedicalINTEGRATED MEDCRAFT LLCOHO2026-07-30