FDA.reportPublic FDA data

Non-rebreathing oxygen face mask

Definition
A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.
GUDID devices
520
Last updated
2026-09-29 04:02:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840155400108MedSource Non-Rebreather MaskMEDSOURCE INTERNATIONAL LLCMS-25058-RCS2021-05-26
00840155400184MedSource Non-Rebreather MaskMEDSOURCE INTERNATIONAL LLCMS-25060-RCS2021-05-27
00848530060961Adult Non-Rebreather Oxygen Mask w/ 7ft safety tubing - High ConcentrationSunset Healthcare Solutions, Inc.RES21022018-09-26
00840117310735Resp-O2 O2 Non-Rebreather Elongated MaskDynarex Corporation330532021-04-22
00840117310759Resp-O2 O2 Non-Rebreather Standard MaskDynarex Corporation330542021-04-22
00840117310773Resp-O2 O2 3-in-1 Elongated MaskDynarex Corporation330552021-04-22
00840117345225Resp-O2 O2 Non-Rebreather Elongated MaskDynarex Corporation33050U2025-05-29
00840117345232Resp-O2 O2 Non-Rebreather Elongated MaskDynarex Corporation33051U2025-05-30
00840117345249Resp-O2 O2 Non-Rebreather Elongated MaskDynarex Corporation33052U2025-05-30
00840117345256Resp-O2 O2 Non-Rebreather Elongated MaskDynarex Corporation33053U2025-05-30
00840117345263Resp-O2 O2 Non-Rebreather Standard MaskDynarex Corporation33054U2025-05-30
00840117345270Resp-O2 O2 3-in-1 Elongated MaskDynarex Corporation33055U2025-05-30
04719874950989Create BiotechCREATE BIOTECH CO., LTD.022-004-1012026-07-21
00840117310674Resp-O2 O2 Non-Rebreather Elongated MaskDynarex Corporation330502021-04-22
00840117310698Resp-O2 O2 Non-Rebreather Elongated MaskDynarex Corporation330512021-04-22
00840117310711Resp-O2 O2 Non-Rebreather Elongated MaskDynarex Corporation330522021-04-22
00607411919039Salter Labs® High Concentration partial rebreatherSALTER LABS131202026-06-10
00607411919336Salter Labs® Percent-O2-Lock® MaskSALTER LABS138152026-06-10
00607411919008Salter Labs® Adult Comfort Face TentSALTER LABS131032026-06-09
00607411919053Salter Labs® Oxygen MaskSALTER LABS131242026-06-09
00607411919060Salter Labs® Oxygen MaskSALTER LABS131252026-06-09
00026072023013BFAllied Medical, LLC640072024-10-11
00026072023464BFAllied Medical, LLC64059-AHP2024-10-11
00199972000061Curaplex®BOUND TREE MEDICAL, LLC8600-015552025-12-17
00607411000331n/aSALTER LABS8057-02016-11-30
00607411000348n/aSALTER LABS8058-72016-11-30
00607411000355n/aSALTER LABS8059-72016-11-30
00607411005718n/aSALTER LABS8145-02016-11-30
00607411008245n/aSALTER LABSSO-4352016-11-30
00607411008252n/aSALTER LABSSO-1216-02016-11-30
00607411009136N/ASALTER LABSM811374-02016-12-16
00607411049828N/ASALTER LABS1110TLC2016-11-30
00607411200908n/aSALTER LABSL8110-7-502016-11-30
00607411201059n/aSALTER LABSL81502016-11-30
00607411300691N/ASALTER LABSM125335-02016-12-16
00607411300707N/ASALTER LABSM124753-02016-12-16
00607411301155N/ASALTER LABS1102-72016-11-30
00607411301186N/ASALTER LABS11032016-11-30
00607411301209N/ASALTER LABS1110-02016-11-30
00607411301407N/ASALTER LABS1130TG-72016-11-30
00607411302022N/ASALTER LABSM124787-02016-12-16
00607411302862N/ASALTER LABSM838142-02016-12-16
00607411401084N/ASALTER LABS10462016-11-30
00607411800054n/aSALTER LABS8005-72016-11-30
00607411800085n/aSALTER LABS8010-02016-11-30
00607411800092n/aSALTER LABS8020-72016-11-30
00607411800115n/aSALTER LABS8030-72016-11-30
00607411800153n/aSALTER LABS8040-72016-11-30
00607411800191n/aSALTER LABS8050-72016-11-30
00607411800214n/aSALTER LABS8054-72016-11-30
00607411800221n/aSALTER LABS8056-02016-11-30
00607411800306n/aSALTER LABS8110-72016-11-30
00607411800313n/aSALTER LABS8110TG-72016-11-30
00607411800320n/aSALTER LABS81152016-11-30
00607411800337n/aSALTER LABS8120-72016-11-30
00607411800351n/aSALTER LABS8121-72016-11-30
00607411800368n/aSALTER LABS8121TG-72016-11-30
00607411800375n/aSALTER LABS8125-02016-11-30
00607411800382n/aSALTER LABS8130-142016-11-30
00607411800412n/aSALTER LABS8130-72016-11-30
00607411800429n/aSALTER LABS8130-92016-11-30
00607411800436n/aSALTER LABS8130TG-72016-11-30
00607411800443n/aSALTER LABS8135-02016-11-30
00607411800450n/aSALTER LABS8140-72016-11-30
00607411800467n/aSALTER LABS8140TG-72016-11-30
00607411800481n/aSALTER LABS8150-72016-11-30
00607411800498n/aSALTER LABS8150TG-72016-11-30
00607411800559N/ASALTER LABS1050-72016-11-30
00607411800726N/ASALTER LABS1122-72016-11-30
00607411800740N/ASALTER LABS11232016-11-30
00607411800757N/ASALTER LABS1127-72016-11-30
00607411800764N/ASALTER LABS1130-72016-11-30
00607411800788N/ASALTER LABS1140-72016-11-30
00607411800818n/aSALTER LABSSO-407-02016-11-30
00607411800825n/aSALTER LABSSO-428-02016-11-30
00607411800832n/aSALTER LABSSO-429-02016-11-30
00607411800849n/aSALTER LABSSO-430-02016-11-30
00607411800900n/aSALTER LABSSO-1111-02016-11-30
00607411800917n/aSALTER LABSSO-1112-02016-11-30
00607411800924n/aSALTER LABS8130-102016-11-30