FDA.reportPublic FDA data

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 is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.
GUDID devices
1,394
Last updated
2026-09-29 04:02:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840155400375MedSource Oxygen MaskMEDSOURCE INTERNATIONAL LLCMS-26041-RCS2021-05-28
00840155400412MedSource Oxygen MaskMEDSOURCE INTERNATIONAL LLCMS-26042-RCS2021-05-28
00848530060947Adult Simple Oxygen Mask w/7' Safety TubingSunset Healthcare Solutions, Inc.RES21002018-09-24
00848530101763Mask for SperaChamber Size Large (Adult)Sunset Healthcare Solutions, Inc.RES195MASK-L2024-03-05
00848530101770Mask for SperaChamber Size Medium (Pediatric)Sunset Healthcare Solutions, Inc.RES195MASK-M2024-03-05
00848530101787Mask for SperaChamber Size Small (Infant)Sunset Healthcare Solutions, Inc.RES195MASK-S2024-03-05
00840118621137Endure IndustriesENDURE INDUSTRIESOMEP112026-08-17
00840118621144Endure IndustriesENDURE INDUSTRIESOMEA112026-08-14
04719874950675Create BiotechCREATE BIOTECH CO., LTD.016-002-0032026-07-21
04719874950972Create BiotechCREATE BIOTECH CO., LTD.022-003-1012026-07-21
04719874951153Create BiotechCREATE BIOTECH CO., LTD.016-002-0012026-07-21
04719874951160Create BiotechCREATE BIOTECH CO., LTD.016-002-0022026-07-21
04719874951177Create BiotechCREATE BIOTECH CO., LTD.016-002-0042026-07-21
04719874951184Create BiotechCREATE BIOTECH CO., LTD.016-002-0052026-07-21
04719874955793Create BiotechCREATE BIOTECH CO., LTD.014-001-0042026-07-21
04719874955809Create BiotechCREATE BIOTECH CO., LTD.014-001-0052026-07-21
04719874955816Create BiotechCREATE BIOTECH CO., LTD.014-001-0062026-07-21
04719874956264Create BiotechCREATE BIOTECH CO., LTD.013-001-0072026-07-21
04719874956271Create BiotechCREATE BIOTECH CO., LTD.013-001-0082026-07-21
04719874956288Create BiotechCREATE BIOTECH CO., LTD.013-001-0092026-07-21
04719874956295Create BiotechCREATE BIOTECH CO., LTD.013-001-0102026-07-21
04719874956301Create BiotechCREATE BIOTECH CO., LTD.013-001-0112026-07-21
04719874956318Create BiotechCREATE BIOTECH CO., LTD.013-001-0122026-07-21
00840117310575Resp-O2 O2 High-Concentration Standard MaskDynarex Corporation330092021-04-22
00840117310599Resp-O2 O2 High-Concentration Elongated MaskDynarex Corporation330102021-04-22
00840117310612Resp-O2 O2 High-Concentration Elongated MaskDynarex Corporation330112021-04-22
00840117310636Resp-O2 O2 High-Concentration Elongated MaskDynarex Corporation330122021-04-22
00840117310650Resp-O2 O2 High-Concentration Elongated MaskDynarex Corporation330132021-04-22
00619498161348AIRFIT F 10RESMED PTY LTD161342018-11-16
00628725095516PEDIATRIC OXYGEN MASK Canadian Hospital Specialties LimitedR-2700SM2024-05-16
00628725095547Face mask - PediatricCanadian Hospital Specialties LimitedR-2755SM2024-05-16
00628725096834Adult Aerosol MaskCanadian Hospital Specialties LimitedR-8421S2024-04-16
00628725096902Adult Oxygen Mask Med.ConcentrationCanadian Hospital Specialties LimitedR-2200SM2024-02-23
00628725096919Adult Oxygen MaskCanadian Hospital Specialties LimitedR-2250SM2024-02-23
00628725096926Adult Oxygen Mask High ConcentrationCanadian Hospital Specialties LimitedR-2450SM2024-02-23
00628725096933Pediatric Non-Rebreathing Oxygen MaskCanadian Hospital Specialties LimitedR-2960SM2024-02-23
00628725096971Pediatric Non-Rebreathing Oxygen MaskCanadian Hospital Specialties LimitedR-2950SM2024-04-22
00628725096988TavishCanadian Hospital Specialties LimitedR-7700S2023-07-06
00628725097015Pediatric Aerosol MaskCanadian Hospital Specialties LimitedR-25002023-06-30
00628725097022JemsdalCanadian Hospital Specialties LimitedA-2512023-06-30
00628725097114Mskk Oxygen Pediatric Non Rebreathing 1 Valve 7' Saflo Oxygen TubingCanadian Hospital Specialties Limited126522023-06-19
00628725097299Non-breathing Oxygen Mask with 7FT Saflo Oxygen Supply TubingCanadian Hospital Specialties LimitedMS-2960S2023-06-16
00628725097343Adult NSA Oxygen MaskCanadian Hospital Specialties LimitedR-90012023-06-27
00628725097411Pediatric Aerosol MaskCanadian Hospital Specialties LimitedR-2500/502023-06-27
00628725097503Adult Oxygen Mask Med. ConcentrationCanadian Hospital Specialties LimitedR-2200S2023-06-22
00628725097558JemsdalCanadian Hospital Specialties LimitedA-2712023-06-27
00628725097619TavishCanadian Hospital Specialties LimitedR-7920S2023-06-26
00628725097671TavishCanadian Hospital Specialties LimitedRIS-70002023-06-15
00628725097770Mask Adult Non Rebreather Two Valves 7' Saflo TubingCanadian Hospital Specialties LimitedMS-2460S2023-06-12
00628725097787Oxygen TubeCanadian Hospital Specialties Limited113402023-06-15
00628725097947Pediatric Aerosol MaskCanadian Hospital Specialties LimitedR-2921S2023-06-27
00628725097954Pediatric Non-rebreathing Oxygen MaskCanadian Hospital Specialties LimitedR-2950S2023-06-14
00628725097961Pediatric Non-Rebreathing Oxygen MaskCanadian Hospital Specialties LimitedR-2960S2023-06-14
00628725098289TavishCanadian Hospital Specialties LimitedR-7200S2023-06-30
00628725098296TavishCanadian Hospital Specialties LimitedR-7450S2023-06-09
00628725098302TavishCanadian Hospital Specialties LimitedR-7450SM2023-06-12
00628725098319TavishCanadian Hospital Specialties LimitedR-75002023-06-09
00628725098371SMALL ADULT 3 IN 1 MASKCanadian Hospital Specialties LimitedR-81552024-04-04
00628725098388Adult Oxygen MaskCanadian Hospital Specialties LimitedR-8200S2023-06-27
00628725098555TavishCanadian Hospital Specialties LimitedR-90002023-06-27
00628725098593TavishCanadian Hospital Specialties LimitedR-9950S2023-06-27
00628725099415Adult Aerosol MaskCanadian Hospital Specialties LimitedR-20002023-06-27
00628725099484Adult Oxygen MaskCanadian Hospital Specialties LimitedR-21002023-06-30
00628725099507Adult 3 IN 1 MaskCanadian Hospital Specialties LimitedR-21552023-06-27
00628725099521Adult High Concentration Oxygen Mask with 7’ Saflo TubeCanadian Hospital Specialties LimitedR-2250S2023-06-14
00628725099545Adult Three-In-One Mask with 7' Saflo TubeCanadian Hospital Specialties LimitedR-2255S2023-06-28
00628725099552Adult Three-In-One Mask with Multi-fit Connector on 7' Saflo TubeCanadian Hospital Specialties LimitedR-2255SM2023-06-28
00628725099675Adult Non-rebreathing Oxygen MaskCanadian Hospital Specialties LimitedR-23502023-06-14
00628725099699ADULT AEROSOL MASK WITH 7FT SAFLO TUBECanadian Hospital Specialties LimitedR-2421S2025-02-13
00628725099705Adult Non-rebreathing Oxygen MaskCanadian Hospital Specialties LimitedR-2450S2023-06-14
00628725099729Adult Non-Rebreathing Oxygen MaskCanadian Hospital Specialties LimitedR-2460S2023-06-14
00628725099767PEDIATRIC THREE-IN-ONE MASKCanadian Hospital Specialties LimitedR-26552024-04-04
00628725099774Pediatric Oxygen MaskCanadian Hospital Specialties LimitedR-2700S2023-06-27
00628725099798Pediatric High Concentration Oxygen MaskCanadian Hospital Specialties LimitedR-2750S2023-06-30
00628725099804Pediatric Three-In-One MaskCanadian Hospital Specialties LimitedR-2755S2023-06-30
00628725099873TavishCanadian Hospital Specialties LimitedR-70002023-06-12
00810071631214CuraplexBOUND TREE MEDICAL, LLC301-180EA2022-12-30
00810071631221CuraplexBOUND TREE MEDICAL, LLC301-180U2022-12-30
00810071631290CuraplexBOUND TREE MEDICAL, LLC301-1892022-12-30
00810071631306CuraplexBOUND TREE MEDICAL, LLC301-189U2022-12-30