FDA.reportPublic FDA data

Curaplex

Primary DI
00812277034936
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
1215-22196
Catalog number
1215-22196
Device description
T.O.C.S. Tactical Occlusive Chest Seal - Vented
Published
2019-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, wound, occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812277034936PackageGS125In Commercial Distribution
00812277034905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812277034936008122770349368122770349360812277034936
00812277034905008122770349058122770349050812277034905

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
Radiation Sterilization

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
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
10885632417122HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-10-21
10885632417146HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-10-21
M689HVPIK060H-Vent Vented Chest SealSafeguard US Operating, LLCNAD2026-10-13
00096295146639LEADERCardinal Health 110, Inc.NAD2026-10-09
08806109104180Madeca Medi Patch SpecialDongkook Pharmaceutical Co.,Ltd.NAD2026-09-30
08806109193573MADECA MEDI PATCH FREE-CUT PATCHDongkook Pharmaceutical Co.,Ltd.NAD2026-09-30
08806109193580MADECA MEDI PATCH FREE-CUT PATCHDongkook Pharmaceutical Co.,Ltd.NAD2026-09-30
00749756399258DeRoyalDEROYAL INDUSTRIES, INC.NAD2026-09-21
07333350341596Mepitel®Mölnlycke Health Care ABNAD2026-09-21
05701780265058Biatain AdhesiveColoplast A/SNAD2026-08-27
04719873697779NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697786NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697793NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697809NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697816NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697823NACARILEX MEDICAL, INC.NAD2026-08-26
00850088144925CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-08-14
040640351931573M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
040640351931953M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
040640351932323M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
05060483573083Russell Chest Seal - Twin (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-24
05060483570006Russell Chest Seal (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-20
00850088144642CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144659CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144697CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144215CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144222CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144239CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144246CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144253CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08