FDA.reportPublic FDA data

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
71
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00812277034905CuraplexBOUND TREE MEDICAL, LLC1215-221962019-07-01
00822045000179SAM Chest SealSAM Medical ProductsCS201-EN2022-09-01
00822045000186SAM Chest SealSAM Medical ProductsCS202-EN2022-09-01
00822045000193SAM Chest SealSAM Medical ProductsCS203-EN2022-09-01
00842209107551NARNORTH AMERICAN RESCUE, LLC10-00292022-12-08
00842209109074NARNORTH AMERICAN RESCUE, LLC10-00372022-12-08
00842209109081NARNORTH AMERICAN RESCUE, LLC10-00422022-12-08
00842209111787NARNORTH AMERICAN RESCUE, LLC85-10452022-12-08
00857048006132Bolin Chest SealH&H MEDICAL CORPORATION62020-12-31
04026704552139RUSCHTELEFLEX INCORPORATEDIPN0452672016-09-16
04026704553754RUSCHTELEFLEX INCORPORATEDIPN0452682016-09-16
04026704569915RUSCHTELEFLEX INCORPORATEDIPN0452692016-09-16
06975675782398Rhino RescueEMSRUN GROUPCHEST SEAL/CPXF0079/1PC2025-10-30
06975675788352Rhino RescueEMSRUN GROUPCHEST SEAL/CPXF0054/2PC2025-10-30
06975675788796Rhino RescueEMSRUN GROUPChest seal/CPXF0041/20pcs2025-11-07
06975675788802Rhino RescueEMSRUN GROUPChest seal/CPXF0040/6pcs2025-11-07
06975675788819Rhino RescueEMSRUN GROUPChest seal/CPXF0039/2pcs2025-11-07
06975675789632Rhino RescueEMSRUN GROUPChest seal/CPXF0038/20pcs2025-11-06
06975675789649Rhino RescueEMSRUN GROUPChest seal/CPXF0029/6pcs2025-11-06
06975675789656Rhino RescueEMSRUN GROUPCHEST SEAL/CPXF0010/2PC2025-10-30
14026704662750RUSCHTELEFLEX INCORPORATEDIPN0296702019-07-24
14026704662767RUSCHTELEFLEX INCORPORATEDIPN0296712019-07-24
15060206630632Foxseal MEDTRADE PRODUCTS LIMITEDFG088144412020-06-30
15060206630694FOXSEAL VentedMEDTRADE PRODUCTS LIMITEDFG088145412022-02-04
15060206630700FOXSEAL - CMSMEDTRADE PRODUCTS LIMITEDFG058144912021-03-31
15060206631295FOXSEAL VentedMEDTRADE PRODUCTS LIMITEDFG088146112022-02-11
15060206631363FOXSEAL MEDTRADE PRODUCTS LIMITEDFG088146212022-03-31
M689BCS01050Bolin Chest SealSafeguard US Operating, LLC052025-10-27
M689HHWSK02050Wound Seal KitSafeguard US Operating, LLC052025-06-24
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 SealSafeguard US Operating, LLC042019-12-16
M68920001030Sentinel Chest SealSafeguard US Operating, LLC032018-10-26
00812277034936CuraplexBOUND TREE MEDICAL, LLC1215-221962019-07-01