FDA.reportPublic FDA data

Pulmonary resuscitator, manual, single-use

Definition
A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.
GUDID devices
4,600
Last updated
2026-10-06 03:49:44

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10889483586358Vital Signs™AIRLIFE5503B2025-02-18
00848530104993RESUSCITATION KITSunset Healthcare Solutions, Inc.RES8100HNS2025-08-20
00848530105037RESUSCITATION KITSunset Healthcare Solutions, Inc.RES85002025-08-20
00848530105044RESUSCITATION KITSunset Healthcare Solutions, Inc.RES84002025-08-20
10889483111185VentlabVENTLAB, LLCVS0600-C2023-07-12
10889483083758VentlabVENTLAB, LLCAF5140MB-F2016-11-16
00199972000474CuraplexBOUND TREE MEDICAL, LLC8600-01558-KIT2026-08-15
00840117308336Resp-O2 Manual Pulmonary Resuscitator (MPR)Dynarex Corporation360052021-04-22
00840117313958Resp-O2 Manual Pulmonary Resuscitator (MPR)Dynarex Corporation360042021-04-22
00840117313972Resp-O2 Infant Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Tubing OxygenDynarex Corporation360062021-04-22
00840117326002RespO2 Manual Pulmonary Resuscitator (MPR)Dynarex Corporation360072023-01-09
00840117308350Resp-O2 Pediatric Manual Pulmonary Resuscitator (MPR) Mask, Reservoir BagDynarex Corporation360032021-04-22
00840117308374Resp-O2 Manual Pulmonary Resuscitator (MPR)Dynarex Corporation360012021-04-22
00840117308398Resp-O2 Manual Pulmonary Resuscitator(MPR)Dynarex Corporation360002021-04-22
06946430410856CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDNPVC-002/RTMA2021-09-15
06946430410870CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDNPVC-003/RTMA12021-09-15
10889483481226Ventlab Hyperinflation SystemVENTLAB, LLCHS4051-W2026-06-24
00709078008825Disposable PEP DevicesWESTMED, INC.02622020-07-31
10889483221747AirLife™SUNMED, LLC02622025-12-19
10889483222157AmbuSUNMED, LLC900-000-6012025-12-19
10889483222164AmbuSUNMED, LLC900-000-6022025-12-19
10889483222188AmbuSUNMED, LLC900-000-6042025-12-19
10889483222195AmbuSUNMED, LLC900-000-6052025-12-19
10889483222201AmbuSUNMED, LLC900-000-6062025-12-19
10889483222225AmbuSUNMED, LLC900-000-6092025-12-19
10889483222232AmbuSUNMED, LLC900-000-6112025-12-19
10889483231494AmbuSUNMED, LLC900-000-6142025-12-19
10889483231524AmbuSUNMED, LLC900-000-6172025-12-19
10889483231531AmbuSUNMED, LLC900-000-6182025-12-19
10889483231586AmbuSUNMED, LLC900-000-6242025-12-19
10889483231616AmbuSUNMED, LLC900-000-6282025-12-19
00616784580111Infant MPRDynarex Corporation58012016-09-24
00616784580418Pediatric MPRDynarex Corporation58042016-09-24
00616784580715Adult MPRDynarex Corporation58072016-09-24
00616784580814Adult MPRDynarex Corporation58082016-09-24
00709078000362Neo-Vent Infant T-Piece Resuscitation CircuitWESTMED, INC.04152016-12-14
00709078000379Neo-Vent Infant T-Piece Resuscitation Circuit, Gas SupplyWESTMED, INC.04162016-12-15
00709078000645Neo-Vent Infant T-Piece Resuscitation Circuit w/Infant MaskWESTMED, INC.04202016-12-15
00709078000652Neo-Vent Infant T-Piece Resuscitation Circuit w/Neonatal MaskWESTMED, INC.04212016-12-14
00709078002441Neo-Vent™,Humidified Infant T-Piece Resuscitation KitWESTMED, INC.04222017-02-02
00709078004667Neo-Vent™WESTMED, INC.04192017-10-27
00709078008061BagEasyWESTMED, INC.5622012019-10-31
00709078008078BagEasyWESTMED, INC.5622022019-10-31
00709078008764Adapters/ConnectorsWESTMED, INC.7-51142020-07-31
00709078013881BagEasy® ResuscitatorWESTMED, INC.R-5620802021-12-31
00709078048364BagEasyWESTMED, INC.562048DM2015-10-24
00709078620485BagEasyWESTMED, INC.5620482015-10-24
00709078620812BagEasyWESTMED, INC.5620812015-10-24
00709078620829BagEasyWESTMED, INC.5620822015-10-24
00709078620843BagEasyWESTMED, INC.5620842015-10-24
00709078620867BagEasyWESTMED, INC.5620862015-10-24
00709078621338BagEasyWESTMED, INC.5621332015-10-24
00709078621369BagEasyWESTMED, INC.5621362015-10-24
00709078621901BagEasyWESTMED, INC.5621902015-10-24
00709078622007BagEasyWESTMED, INC.5622002015-10-24
00709078622038BagEasyWESTMED, INC.5622032015-10-24
00709078622335BagEasyWESTMED, INC.5622332015-10-24
00709078622342BagEasyWESTMED, INC.5622342015-10-24
00709078622359BagEasyWESTMED, INC.5622352015-10-24
00709078622366BagEasyWESTMED, INC.5622362015-10-24
00709078622373BagEasyWESTMED, INC.5622372015-10-24
00810071633119CuraplexBOUND TREE MEDICAL, LLC2442-BVMCIN2023-09-30
00810094576042Curaplex®BOUND TREE MEDICAL, LLC2442-BVMPAA2023-08-30
00810094576059Curaplex®BOUND TREE MEDICAL, LLC2442-BVMPIC2023-08-30
00810094577537Curaplex®BOUND TREE MEDICAL, LLC2442-BVMPAD-ET2024-11-30
00810094577544Curaplex®BOUND TREE MEDICAL, LLC2442-BVMPSA-ET2024-11-30
00810094578398Curaplex®BOUND TREE MEDICAL, LLC8600-015222025-07-09
00812277035292CuraplexBOUND TREE MEDICAL, LLC301-BVM3002019-08-30
00812277035308CuraplexBOUND TREE MEDICAL, LLC301-BVM5502019-08-30
00812277035315CuraplexBOUND TREE MEDICAL, LLC301-BVM10002019-08-30
00812277035322CuraplexBOUND TREE MEDICAL, LLC301-BVM15002019-08-30
00812277037012CuraplexBOUND TREE MEDICAL, LLCAF50002021-09-30
00812277037029CuraplexBOUND TREE MEDICAL, LLCAF20002021-09-30
00812277037036CuraplexBOUND TREE MEDICAL, LLCAF40002021-09-30
00812277037043CuraplexBOUND TREE MEDICAL, LLCAF30002021-09-30
00812574023992CuraplexTRI-ANIM HEALTH SERVICES, INC.301-C20002016-12-16
00812574025545CuraplexTRI-ANIM HEALTH SERVICES, INC.301-C15002016-12-16
00812574025552CuraplexTRI-ANIM HEALTH SERVICES, INC.301-C10002016-12-16
00812574025712CuraplexTRI-ANIM HEALTH SERVICES, INC.301-C25002016-12-16
00812574026191CuraplexTRI-ANIM HEALTH SERVICES, INC.301-C20002017-02-06