FDA.reportPublic FDA data

Pleural/peritoneal drainage catheterization kit, non-medicated

Definition
A collection of non-powered devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions (e.g., haemothorax, empyema, ascites), other fluids, and/or air; some types are additionally intended for infusion of fluids/materials into the pleural/peritoneal space. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller), non-dedicated catheterization support devices (e.g., dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device.
GUDID devices
132
Last updated
2026-10-13 01:08:03

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10885403076008DenverCAREFUSION 2200, INC42-20552017-06-12
00884450545010Aspira®Merit Medical Systems, Inc.Initial Release2026-07-25
00884450545034Aspira®Merit Medical Systems, Inc.Initial Release2026-07-25
00860011648116Automatic Continuous Effusion System (ACES) KitPleural Dynamics, Inc.AK01-12026-07-13
00628725095363Pleural Drain Dry Seal System CHS USA Inc.H031002026-04-17
00628725095370Pleural Drain Wet Seal System CHS USA Inc.H030042026-04-17
00748426075690MICROTEKMicrotek Medical LLC12016-11-04
00801741045011Aspira Dressing KitBard Access Systems, Inc.49915032015-11-20
00801741045028Aspira Drainage Catheter TrayBard Access Systems, Inc.49922062015-12-04
00801741045035Aspira Drainage KitBard Access Systems, Inc.49923012015-11-20
00801741045042Aspira Luer AdapterBard Access Systems, Inc.49923052015-11-20
00801741045059Aspira Valve Repair KitBard Access Systems, Inc.49923062015-11-20
00801741045066Aspira Universal AdapterBard Access Systems, Inc.49923072015-11-20
00801741045073Aspira Drainage TrayBard Access Systems, Inc.49925062015-11-20
00801741230608PeritXBard Peripheral Vascular, Inc.90-20102025-01-23
00801741230615PeritXBard Peripheral Vascular, Inc.90-20052025-01-23
00801741230639PeritXBard Peripheral Vascular, Inc.90-20202025-01-23
00801902004772ARROWTELEFLEX INCORPORATEDIPN0108112016-09-16
00801902005236ARROWTELEFLEX INCORPORATEDIPN0338702016-09-16
00801902077080ARROWTELEFLEX INCORPORATEDIPN0341642016-09-16
00801902083517ARROWTELEFLEX INCORPORATEDIPN0341632016-09-16
00801902111432ARROWTELEFLEX INCORPORATEDIPN0326362016-09-16
00813623011144ASEPT Peritoneal Drainage SystemPFM MEDICAL INCORPORATED6222792016-10-01
00813623015371ASEPT Peritoneal Drainage SystemPFM MEDICAL INCORPORATEDM70002015-10-15
00813623017016ASEPT Pleural Drainage SystemPFM MEDICAL INCORPORATEDM70012016-10-02
00860099001346Passio Catheter Valve Replacement KitBearpac Medical, LLCPAS-052023-08-25
00860099001391Passio Valve Cap KitBearpac Medical, LLCPAS-132024-02-29
00884450394861Aspira®Merit Medical Systems, Inc.008844503948612019-09-23
00884450394878Aspira®Merit Medical Systems, Inc.008844503948782019-11-25
00884450394885Aspira®Merit Medical Systems, Inc.008844503948852019-11-14
00884450394892Aspira®Merit Medical Systems, Inc.008844503948922019-11-15
00884450394908Aspira®Merit Medical Systems, Inc.008844503949082019-12-26
00884450394915Aspira®Merit Medical Systems, Inc.008844503949152019-12-05
00884450394922Aspira®Merit Medical Systems, Inc.008844503949222020-07-24
00884450394939Aspira®Merit Medical Systems, Inc.008844503949392020-02-13
00884450394946Aspira®Merit Medical Systems, Inc.008844503949462019-11-27
00884450394953Aspira®Merit Medical Systems, Inc.008844503949532020-02-04
00884450394960Aspira®Merit Medical Systems, Inc.008844503949602020-07-14
00884450394977Aspira®Merit Medical Systems, Inc.008844503949772020-03-20
00884450394984Aspira®Merit Medical Systems, Inc.008844503949842019-11-14
00884450398166Aspira®Merit Medical Systems, Inc.008844503981662020-01-31
00884450398173Aspira®Merit Medical Systems, Inc.008844503981732019-12-30
00884450534304Aspira®Merit Medical Systems, Inc.008844505343042022-03-16
00884450534311Aspira®Merit Medical Systems, Inc.008844505343112022-12-07
00884450544952Aspira®Merit Medical Systems, Inc.A2024-03-06
00884450544969Aspira®Merit Medical Systems, Inc.A2025-04-21
00884450544990Aspira®Merit Medical Systems, Inc.008844505449902024-01-30
00884450620526Aspira®Merit Medical Systems, Inc.B2026-02-27
00884450620540Aspira®Merit Medical Systems, Inc.B2026-02-27
00884450620557Aspira®Merit Medical Systems, Inc.B2025-06-03
00884450620564Aspira®Merit Medical Systems, Inc.B2026-02-27
00884450620588Aspira®Merit Medical Systems, Inc.B2026-03-05
00884450620595Aspira®Merit Medical Systems, Inc.B2026-02-27
00884450620601Aspira®Merit Medical Systems, Inc.B2025-10-02
00884450620625Aspira®Merit Medical Systems, Inc.B2025-05-29
00884450620632Aspira®Merit Medical Systems, Inc.B2025-01-23
00884450620649Aspira®Merit Medical Systems, Inc.B2025-10-21
00884450634905ReSolve®Merit Medical Systems, Inc.008844506349052022-03-29
00884450680100ReSolve®Merit Medical Systems, Inc.008844506801002022-08-05
00884450680117ReSolve®Merit Medical Systems, Inc.B2025-04-21
00884450772515Aspira®Merit Medical Systems, Inc.A2026-03-27
04026704417469PLEUR-EVACTELEFLEX INCORPORATEDIPN0254252015-12-08
04026704418664TAUTTELEFLEX INCORPORATEDIPN0049352018-09-15
05055270982339RocketROCKET MEDICAL PLCR54400-00-002023-10-20
05055270982643RocketROCKET MEDICAL PLCR54410-WB-DL2023-10-23
05055270982667RocketROCKET MEDICAL PLCR54400-00-RK2023-10-23
10801902004779ARROWTELEFLEX INCORPORATEDIPN0108112017-07-26
10801902005240ARROWTELEFLEX INCORPORATEDIPN0326352019-03-07
10801902120103ARROWTELEFLEX INCORPORATEDIPN0363632016-09-16
10801902120172ARROWTELEFLEX INCORPORATEDIPN0370172016-09-16
10801902120189ARROWTELEFLEX INCORPORATEDIPN0366942016-09-16
10801902121728ARROWTELEFLEX INCORPORATEDIPN0369862016-09-16
10801902145816ARROWTELEFLEX INCORPORATEDIPN0398052019-07-09
10801902145830ARROWTELEFLEX INCORPORATEDIPN0398072019-07-09
10801902162929ARROWTELEFLEX INCORPORATEDIPN9156682020-04-28
10801902197945ARROWTELEFLEX INCORPORATEDIPN9208012022-11-09
10809160009611Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.590642016-08-20
10809160018194Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.730002016-08-20
10809160169469Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.774552017-11-08
10809160281499Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.73000B2020-04-01