FDA.report

Pneumothorax dressing

Definition
A 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.
GUDID devices
42
Last updated
2025-09-02 16:05:25

Related Product Codes

CodeDeviceSpecialtyClassDevices
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery128
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery18
MGPDressing, Wound And Burn, OcclusiveUnknownU3
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery12
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
20842209109078NARNORTH AMERICAN RESCUE, LLC10-00372025-08-25
M68920001070Sentinel Chest SealSafeguard US Operating, LLC072024-10-30
M689HHWSK02040 Chest Wound Seal KitSafeguard US Operating, LLC042024-09-04
15060206631653Foxseal Vented MEDTRADE PRODUCTS LIMITEDFG07014691 2024-08-30
00842209132515NARNORTH AMERICAN RESCUE, LLC85-40772024-08-14
00842209129904NARNORTH AMERICAN RESCUE, LLC10-00732024-06-27
M689BCS01040Bolin Chest SealSafeguard US Operating, LLC042023-10-05
05060483570365Russell Chest Seal (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDPDF06802023-05-04
00810094575519CuraplexBOUND TREE MEDICAL, LLC670262-KIT2023-03-30
00810094575526CuraplexBOUND TREE MEDICAL, LLC670263-KIT2023-03-30
M689HHPCIKCA010Penetrating Chest Injury Kit case of 25Safeguard US Operating, LLC012022-11-30
00842209109067NARNORTH AMERICAN RESCUE, LLC10-00152022-11-28
06974567740881EMSRUNWuxi Emsrun Technology Co., Ltd.CR-CS022022-11-25
M689HVS03010H-VentSafeguard US Operating, LLC012022-09-07
10822045000183SAM Chest SealSAM Medical ProductsCS202-EN2022-09-01
10822045000190SAM Chest SealSAM Medical ProductsCS203-EN2022-09-01
20822045000173SAM Chest SealSAM Medical ProductsCS201-EN2022-09-01
M689HHWSK02020 Chest Wound Seal KitSafeguard US Operating, LLC022022-08-11
M689HHWSK01040 Wound Seal KitSafeguard US Operating, LLC042022-08-10
75060206631365FOXSEAL MEDTRADE PRODUCTS LIMITEDFG088146212022-03-31
15060206631288FOXSEAL VentedMEDTRADE PRODUCTS LIMITEDFG088146012022-02-11
75060206631297FOXSEAL VentedMEDTRADE PRODUCTS LIMITEDFG088146112022-02-11
75060206630696FOXSEAL VentedMEDTRADE PRODUCTS LIMITEDFG088145412022-02-04
00840155403581MedSource Halo Chest SealMEDSOURCE INTERNATIONAL LLCMS-G11632021-08-03
00840155404366MedSource Chest SealMEDSOURCE INTERNATIONAL LLCMS-BCS012021-07-28
75060206630702FOXSEAL - CMSMEDTRADE PRODUCTS LIMITEDFG058144912021-03-31
24026704553758RUSCHTELEFLEX INCORPORATEDIPN0452682016-09-16
00857048006156Compact Wound SealH&H MEDICAL CORPORATION12020-12-31
00857048006163Wound Seal DuoH&H MEDICAL CORPORATION12020-12-31
00857048006170Penetrating Chest Injury KitH&H MEDICAL CORPORATION12020-12-31
00857048006279Wound Seal KitH&H MEDICAL CORPORATION12020-12-31
00857048006286Bolin Chest SealH&H MEDICAL CORPORATION62020-12-31
00857048006378DualSeal Chest SealsH&H MEDICAL CORPORATION12020-12-31
00857048006385H*VENT Vented Chest SealH&H MEDICAL CORPORATION12020-12-31
00857048006439H*VENT Penetrating Injury KitH&H MEDICAL CORPORATION12020-12-31
00857048006460H*VENT Vented Chest Seal Two-PackH&H MEDICAL CORPORATION12020-12-31
75060206630634Foxseal MEDTRADE PRODUCTS LIMITEDFG088144412020-06-30
24026704662757RUSCHTELEFLEX INCORPORATEDIPN0296702019-07-24
24026704662764RUSCHTELEFLEX INCORPORATEDIPN0296712019-07-24
M68920001040Sentinel Chest SealCOMBAT MEDICAL SYSTEMS, LLC042019-12-16
M68920001030Sentinel Chest SealCOMBAT MEDICAL SYSTEMS, LLC032018-10-26
00812277034936CuraplexBOUND TREE MEDICAL, LLC1215-221962019-07-01