FDA.reportPublic FDA data

Partial-rebreathing oxygen face mask

Definition
A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It includes a reservoir bag used for inhaling a mixture of exhaled and fresh gases. It is made of non-conductive, soft, flexible polymers available in a range of sizes, designed to create an airtight seal against the patient's face and may also include tubing, and various valves and connectors; other equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.
GUDID devices
71
Last updated
2026-07-30 21:31:11

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840117310391Resp-O2 O2 Medium-Concentration Standard Mask, 7' (2.1 m) Crush Resistant TubingDynarex Corporation330002021-04-22
00840117310414Resp-O2 O2 Medium-Concentration Standard MaskDynarex Corporation330012021-04-22
00840117310438Resp-O2 O2 Medium-Concentration Standard MaskDynarex Corporation330022021-04-22
00840117310452Resp-O2 O2 Medium-Concentration Standard MaskDynarex Corporation330032021-04-22
00840117310476Resp-O2 O2 Medium-Concentration Standard MaskDynarex Corporation330042021-04-22
00840117310490Resp-O2 O2 Medium-Concentration Elongated MaskDynarex Corporation330052021-04-22
00840117310513Resp-O2 O2 Medium-Concentration Elongated MaskDynarex Corporation330062021-04-22
00840117310537Resp-O2 O2 Medium-Concentration Elongated MaskDynarex Corporation330072021-04-22
00840117310551Resp-O2 O2 Medium-Concentration Elongated MaskDynarex Corporation330082021-04-22
00709078009167Device Respiratory Accessory KitWESTMED, INC.07912020-08-31
04026704389490HUDSON RCITELEFLEX INCORPORATEDIPN0443662018-09-15
04026704389568HUDSON RCITELEFLEX INCORPORATEDIPN0443742018-09-15
04026704543243RUSCHTELEFLEX INCORPORATEDIPN0443132020-01-23
04026704543250RUSCHTELEFLEX INCORPORATEDIPN0443142018-09-15
04026704543274RUSCHTELEFLEX INCORPORATEDIPN0443152018-09-15
04026704543281RUSCHTELEFLEX INCORPORATEDIPN0443162018-09-15
04026704580064HUDSON RCITELEFLEX INCORPORATEDIPN0406672018-09-15
04026704580446HUDSON RCITELEFLEX INCORPORATEDIPN0451692018-09-15
04026704580453HUDSON RCITELEFLEX INCORPORATEDIPN0451712018-09-15
04026704594184HUDSON RCITELEFLEX INCORPORATEDIPN0408142018-09-15
04026704594191HUDSON RCITELEFLEX INCORPORATEDIPN0408242018-09-15
04026704594207HUDSON RCITELEFLEX INCORPORATEDIPN0408252018-09-15
04026704594221HUDSON RCITELEFLEX INCORPORATEDIPN0409772018-09-15
14026704647979HUDSON RCITELEFLEX INCORPORATEDIPN9138802019-05-09
14026704647986HUDSON RCITELEFLEX INCORPORATEDIPN9138812019-05-09
14026704647993HUDSON RCITELEFLEX INCORPORATEDIPN9138822019-05-09
14026704648006HUDSON RCITELEFLEX INCORPORATEDIPN9138832019-05-09
14026704648341HUDSON RCITELEFLEX INCORPORATEDIPN9140002019-05-09
14026704648426HUDSON RCITELEFLEX INCORPORATEDIPN9140082019-05-09
14026704657183RUSCHTELEFLEX INCORPORATEDIPN9139962019-05-09
14026704657206RUSCHTELEFLEX INCORPORATEDIPN9139982019-05-09
14026704657213RUSCHTELEFLEX INCORPORATEDIPN9139992019-05-09
14026704657459HUDSON RCITELEFLEX INCORPORATEDIPN9140472019-05-09
14026704657466HUDSON RCITELEFLEX INCORPORATEDIPN9140482019-05-09
00840117310407Resp-O2 Oxygen Mask Medium-ConcentrationDYNAREX CORPORATION330002021-04-22
00840117310421Resp-O2 Oxygen Mask Medium-ConcentrationDYNAREX CORPORATION330012021-04-22
00840117310445Resp-O2 Oxygen Mask Medium-ConcentrationDYNAREX CORPORATION330022021-04-22
00840117310469Resp-O2 Oxygen Mask Medium-ConcentrationDYNAREX CORPORATION330032021-04-22
00840117310483Resp-O2 Oxygen Mask Medium-ConcentrationDYNAREX CORPORATION330042021-04-22
00840117310506Resp-O2 Oxygen Mask Medium-ConcentrationDYNAREX CORPORATION330052021-04-22
00840117310520Resp-O2 Oxygen Mask Medium-ConcentrationDYNAREX CORPORATION330062021-04-22
00840117310544Resp-O2 Oxygen Mask Medium-ConcentrationDYNAREX CORPORATION330072021-04-22
00840117310568Resp-O2 Oxygen Mask Medium-ConcentrationDYNAREX CORPORATION330082021-04-22
10709078009164Device Respiratory Accessory KitWESTMED, INC.07912020-08-31
24026704389494HUDSON RCITELEFLEX INCORPORATEDIPN0443662018-09-15
24026704389562HUDSON RCITELEFLEX INCORPORATEDIPN0443742018-09-15
24026704543247RUSCHTELEFLEX INCORPORATEDIPN0443132020-01-23
24026704580068HUDSON RCITELEFLEX INCORPORATEDIPN0406672018-09-15
24026704594188HUDSON RCITELEFLEX INCORPORATEDIPN0408142018-09-15
24026704594195HUDSON RCITELEFLEX INCORPORATEDIPN0408242018-09-15
24026704594201HUDSON RCITELEFLEX INCORPORATEDIPN0408252018-09-15
24026704594225HUDSON RCITELEFLEX INCORPORATEDIPN0409772018-09-15
24026704543254RUSCHTELEFLEX INCORPORATEDIPN0443142018-09-15
24026704543278RUSCHTELEFLEX INCORPORATEDIPN0443152018-09-15
24026704543285RUSCHTELEFLEX INCORPORATEDIPN0443162018-09-15
24026704580440HUDSON RCITELEFLEX INCORPORATEDIPN0451692018-09-15
24026704580457HUDSON RCITELEFLEX INCORPORATEDIPN0451712018-09-15
14026704657503HUDSON RCITELEFLEX INCORPORATEDIPN9140522019-05-09
24026704647976HUDSON RCITELEFLEX INCORPORATEDIPN9138802019-05-09
24026704647983HUDSON RCITELEFLEX INCORPORATEDIPN9138812019-05-09
24026704647990HUDSON RCITELEFLEX INCORPORATEDIPN9138822019-05-09
24026704648003HUDSON RCITELEFLEX INCORPORATEDIPN9138832019-05-09
24026704648348HUDSON RCITELEFLEX INCORPORATEDIPN9140002019-05-09
24026704648423HUDSON RCITELEFLEX INCORPORATEDIPN9140082019-05-09
24026704657180RUSCHTELEFLEX INCORPORATEDIPN9139962019-05-09
24026704657203RUSCHTELEFLEX INCORPORATEDIPN9139982019-05-09
24026704657210RUSCHTELEFLEX INCORPORATEDIPN9139992019-05-09
24026704657463HUDSON RCITELEFLEX INCORPORATEDIPN9140482019-05-09
34026704657453HUDSON RCITELEFLEX INCORPORATEDIPN9140472019-05-09
24026704580471HUDSON RCITELEFLEX INCORPORATEDIPN0451792018-09-15
00874750000036N/AHANS RUDOLPH, INC.75002017-11-14