FDA.reportPublic FDA data

Nitric oxide delivery unit, system-based

Definition
A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.
GUDID devices
184
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810055280100INOmaxMallinckrodt Manufacturing LLC503722024-03-29
00810055280117INOmaxMallinckrodt Manufacturing LLC503832024-03-29
00810055280131INOmaxMallinckrodt Manufacturing LLC503872024-03-29
00810055280148INOmaxMallinckrodt Manufacturing LLC908552024-03-29
00810055280155INOmaxMallinckrodt Manufacturing LLC912702024-03-29
00810055280261INOmaxMallinckrodt Manufacturing LLC914252021-10-28
00810055280292INOmaxMallinckrodt Manufacturing LLC811262021-10-28
00810055280865INOmaxMallinckrodt Manufacturing LLC810862023-05-10
00810055280872INOmaxMallinckrodt Manufacturing LLC810872023-05-10
00810055280889INOmaxMallinckrodt Manufacturing LLC810882021-08-06
00810055280902INOmaxMallinckrodt Manufacturing LLC810902023-05-10
00810055280919INOmaxMallinckrodt Manufacturing LLC810912023-05-10
00810055280926INOmaxMallinckrodt Manufacturing LLC810922023-05-10
00810055281244INOmaxMallinckrodt Manufacturing LLC811242024-08-19
00810055283439INOmaxMallinckrodt Manufacturing LLC913432023-05-10
00810055283446INOmaxMallinckrodt Manufacturing LLC913442021-08-06
00810055283453INOmaxMallinckrodt Manufacturing LLC913452023-05-10
00810055283460INOmaxMallinckrodt Manufacturing LLC913462023-05-10
00810055283477INOmaxMallinckrodt Manufacturing LLC913472021-08-06
00810055283484INOmaxMallinckrodt Manufacturing LLC913482021-08-06
00810055283491INOmaxMallinckrodt Manufacturing LLC913492023-05-10
00810055283507INOmaxMallinckrodt Manufacturing LLC913502023-05-10
00810055283521INOmaxMallinckrodt Manufacturing LLC913522021-08-06
00810055283538INOmaxMallinckrodt Manufacturing LLC913532023-05-10
00810055284023INOmaxMallinckrodt Manufacturing LLC504022021-08-06
00810055284030INOmaxMallinckrodt Manufacturing LLC504032021-08-06
00810055284153INOmaxMallinckrodt Manufacturing LLC504152021-08-06
00810055284177INOmaxMallinckrodt Manufacturing LLC504172023-05-10
00810055284283INOmaxMallinckrodt Manufacturing LLC504282021-08-06
00850000962330GENOSYL®VERO BIOTECH INC.602524-012026-05-06
00850000962347GENOSYL®VERO BIOTECH INC.602013-042026-05-06
00850000962484GENOSYL®VERO BIOTECH INC.601758-042026-05-06
00850046301001NOxBOXi System-I Test KitLinde Gas & Equipment Inc.12023-02-13
00850046301025NOxBOXi NOXKIT 1-10Linde Gas & Equipment Inc.12023-05-01
00850046301049NOxBOXi NOXKIT 2-12Linde Gas & Equipment Inc.12023-05-01
00850046301063NOxBOXi NOXKIT 2-22Linde Gas & Equipment Inc.12023-05-01
00850046301087NOxBOXi NOXKIT 2-15Linde Gas & Equipment Inc.12023-05-01
00850046301100NOxBOXi NOXKIT HFJVLinde Gas & Equipment Inc.12023-05-01
00850046301124NOxBOXi NOXKIT EMERLinde Gas & Equipment Inc.12023-05-01
00850046301148NOxBOXi NOxFLOWLinde Gas & Equipment Inc.12023-08-30
05060541640030NOxBOXiNOXBOX LTDNOXKIT-2-222018-11-05
05060541640047NOxBOXiNOXBOX LTDNOXKIT-2-152018-11-05
05060541640054NOxBOXiNOXBOX LTDNOXKIT-1-102018-11-05
05060541640061NOxBOXiNOXBOX LTDNOXKIT-2-122018-11-05
05060541640078NOxBOXiNOXBOX LTDNOXBOX-I TEST2018-11-05
05060541640085NOxBOXiNOXBOX LTDNOXKIT-HFJV2018-11-05
15060541640112NOxBOXiNOXBOX LTDFXS5552018-11-05
15060541640129NOxBOXiNOXBOX LTDFIL0632018-11-05
15060541640136NOxBOXiNOXBOX LTDFIL0642018-11-05
15060541640143NOxBOXiNOXBOX LTDCON1582018-11-05
B88280011122M-6mm Connector - MultipackBeyond Air, Inc.800112023-08-16
B882900050LungFit PH Bagging KitBeyond Air, Inc.900052022-08-04
B88290006010mm Gas Sample AdaptorBeyond Air, Inc.900062022-08-04
B88290007015mm Gas Sample Adaptor KitBeyond Air, Inc.900072022-08-04
B882900080LungFit PH NO2 FilterBeyond Air, Inc.900082022-08-04
B882900090LungFit PH NO2 Bagging FilterBeyond Air, Inc.900092022-08-04
B882900140LungFit PH NDM Assembly KitBeyond Air, Inc.900142022-08-04
B882900150LungFit PH Verification KitBeyond Air, Inc.900152022-08-04
B882900160Luer Elbow 7.6mm Port KitBeyond Air, Inc.900162022-08-04
B88290017022mm Gas Sample Adaptor KitBeyond Air, Inc.900172022-08-04
B882800130LungFit PH Breathing Circuit 1 KitBeyond Air, Inc.800132025-05-19
B882800120LungFit PH Breathing Circuit 2 KitBeyond Air, Inc.800122025-02-13
00810055280063INOmaxMallinckrodt Manufacturing LLC100952024-03-29
00810055280070INOmaxMallinckrodt Manufacturing LLC101072024-03-29
00810055280087INOmaxMallinckrodt Manufacturing LLC502802024-03-29
00810055280094INOmaxMallinckrodt Manufacturing LLC503122024-03-29
00810055280162INOmaxMallinckrodt Manufacturing LLC503702024-03-29
00810055280179INOmaxMallinckrodt Manufacturing LLC503712024-03-29
10810055280107INOmaxMallinckrodt Manufacturing LLC503722024-03-29
10810055280114INOmaxMallinckrodt Manufacturing LLC503832024-03-29
10810055280138INOmaxMallinckrodt Manufacturing LLC503872024-03-29
10810055280145INOmaxMallinckrodt Manufacturing LLC908552024-03-29
10810055280152INOmaxMallinckrodt Manufacturing LLC912702024-03-29
00850046301209NOxBOXi NOXKIT 3-22Linde Gas & Equipment Inc.12024-01-26
00850046301223NOxBOXi NOXKIT 3-HFJVLinde Gas & Equipment Inc.12024-01-26
03760333380671Ulspira TSAirgas Therapeutics, LLCULSPIRA TS2024-01-02
00850000962262GENOSYL®VERO BIOTECH INC.600943-012023-10-06
00850000962279GENOSYL®VERO BIOTECH INC.601745-012023-10-06
00850000962286GENOSYL®VERO BIOTECH INC.601743-012023-10-06
00850000962293GENOSYL®VERO BIOTECH INC.601747-012023-10-06