FDA.reportPublic FDA data

Fixed-regulator oxygen refillable cylinder

Definition
A container designed as a refillable cylinder with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes.
GUDID devices
32
Last updated
2026-09-29 04:01:37

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00848530100469Oxygen RegulatorSunset Healthcare Solutions, Inc.RES046PL2024-06-03
00848530101886Respiratory AccessorySunset Healthcare Solutions, Inc.RES031-CHAIN2024-06-06
00885304002598DeVilbissDEVILBISS HEALTHCARE LLC535D-C-CF-RE2020-04-03
00885304002635DeVilbissDEVILBISS HEALTHCARE LLC535D-E-8702020-04-03
00885304007166DeVilbissDEVILBISS HEALTHCARE LLC505DZ-6432020-02-07
00885304020585DeVilbissDEVILBISS HEALTHCARE LLCDV6X-6192020-02-07
00885304022473DeVilbissDEVILBISS HEALTHCARE LLC1025KS2020-04-03
00815160020498MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INC1301M2023-09-02
00815160020504MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INC1301ME2023-09-02
00815160021297MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INC1415MS2023-09-02
00815160021303MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INC1529E2023-09-02
00815160021327MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INC1515A-152023-09-02
00815160021334MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INC1630-152023-09-02
00815160021341MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INC1630-A152023-09-02
00815160021358MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INC1630A-15E2023-09-02
00815160021365MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INC16302023-09-02
00815160021372MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INC1616-15E2023-09-02
00815160021389MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INC1630M-15E2023-09-02
00815160021396MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INC1616-AE2023-09-02
00092237601549ROSCOEDrive Devilbiss HealthcareRMI-04H2022-12-08
00092237603505ROSCOEDrive Devilbiss HealthcareRMI-04ST2022-12-08
00092237603536ROSCOEDrive Devilbiss HealthcareRMI-08MINI2022-12-08
00092237603550ROSCOEDrive Devilbiss HealthcareRMI-08ST2022-12-08
00092237603567ROSCOEDrive Devilbiss HealthcareRMI-15H2022-12-08
00092237603581ROSCOEDrive Devilbiss HealthcareRMI-15MINI2022-12-08
00092237603604ROSCOEDrive Devilbiss HealthcareRMI-15ST2022-12-08
05060488573149Protekt Regulator PROACTIVE MEDICAL PRODUCTS, LLCPMREG015B2022-10-13
05060488573156Protekt Regulator PROACTIVE MEDICAL PRODUCTS, LLCPMREG015BM2022-10-13
05060488573163Protekt Regulator PROACTIVE MEDICAL PRODUCTS, LLCPMREG015D2022-10-13
05060488573170Protekt Regulator PROACTIVE MEDICAL PRODUCTS, LLCPMREG04B2022-10-13
05060488573187Protekt Regulator PROACTIVE MEDICAL PRODUCTS, LLCPMREG04D2022-10-13
05060488573194Protekt Regulator PROACTIVE MEDICAL PRODUCTS, LLCPMREG08B2022-10-13