FDA.reportPublic FDA data

Anaesthesia face mask, single-use

Definition
A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.
GUDID devices
1,350
Last updated
2026-09-29 04:01:45

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00848530094942AnesthesiaSunset Healthcare Solutions, Inc.AAM10012024-07-22
00848530094959AnesthesiaSunset Healthcare Solutions, Inc.AAM10022024-07-22
00848530094966AnesthesiaSunset Healthcare Solutions, Inc.AAM10032024-07-22
00848530094973AnesthesiaSunset Healthcare Solutions, Inc.AAM10042024-07-22
00848530094980AnesthesiaSunset Healthcare Solutions, Inc.AAM10052024-07-22
00848530094997AnesthesiaSunset Healthcare Solutions, Inc.AAM10062024-07-22
00848530095000AnesthesiaSunset Healthcare Solutions, Inc.AAM10072024-07-22
00840118623681Endure IndustriesENDURE INDUSTRIESAMT3T2026-08-14
06946430427496CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTD0#2026-08-08
06946430427519CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTD1#2026-08-08
06946430427533CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTD2#2026-08-08
06946430427557CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTD3#2026-08-08
06946430427571CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTD4#2026-08-08
06946430427595CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTD5#2026-08-08
06946430427618CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTD6#2026-08-08
14026704665010HUDSON RCITELEFLEX INCORPORATEDIPN0396792026-08-01
14026704665188HUDSON RCITELEFLEX INCORPORATEDIPN0396962026-08-01
14026704665218HUDSON RCITELEFLEX INCORPORATEDIPN0396992026-08-01
14026704665225HUDSON RCITELEFLEX INCORPORATEDIPN0397002026-08-01
14026704665232HUDSON RCITELEFLEX INCORPORATEDIPN0397012026-08-01
14026704665249HUDSON RCITELEFLEX INCORPORATEDIPN0397022026-08-01
14026704665256HUDSON RCITELEFLEX INCORPORATEDIPN0397032026-08-01
14026704665263HUDSON RCITELEFLEX INCORPORATEDIPN0397042026-08-01
14026704665270HUDSON RCITELEFLEX INCORPORATEDIPN0397052026-08-01
00840117321670Resp-O2 Air Cushion Mask with Valve, Size #0, Preemie/NeonatalDynarex Corporation360302022-10-03
00840117321687Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/InfantDynarex Corporation360312022-10-03
00840117321694Resp-O2 Air Cushion Mask with Valve, Size #2, Toddler, (Yellow Hook)Dynarex Corporation360322022-10-03
00840117321700Resp-O2 Air Cushion Mask with Valve, Size #3, Child/Small Adult (Green Hook)Dynarex Corporation360332022-10-03
00840117321717Resp-O2 Air Cushion Mask with Valve, Size #4, Medium Adult, (Red Hook)Dynarex Corporation360342022-10-03
00840117321724Resp-O2 Air Cushion Mask with Valve, Size #5, Large Adult (Blue Hook)Dynarex Corporation360352022-10-03
14026704665041RUSCHTELEFLEX INCORPORATEDIPN0396822026-07-30
14026704665065RUSCHTELEFLEX INCORPORATEDIPN0396842026-07-30
14026704665072RUSCHTELEFLEX INCORPORATEDIPN0396852026-07-30
14026704665089RUSCHTELEFLEX INCORPORATEDIPN0396862026-07-30
14026704665096RUSCHTELEFLEX INCORPORATEDIPN0396872026-07-30
10190752118973Vital Signs™AIRLIFE5236AAE2019-12-20
10192253072037CARDINAL HEALTHCardinal Health 200, LLCALMASK52026-07-29
10192253072044CARDINAL HEALTHCardinal Health 200, LLCAMMASK42026-07-29
10192253072051CARDINAL HEALTHCardinal Health 200, LLCAXLMASK62026-07-29
10192253072068CARDINAL HEALTHCardinal Health 200, LLCCHIMASK32026-07-29
10192253072075CARDINAL HEALTHCardinal Health 200, LLCINFMASK12026-07-29
10192253072082CARDINAL HEALTHCardinal Health 200, LLCNEOMASK02026-07-29
10192253072105CARDINAL HEALTHCardinal Health 200, LLCTODMASK22026-07-29
10889483585627Vital Signs™AIRLIFE5236AAE2025-02-17
10192253071405CARDINAL HEALTHCardinal Health 200, LLCALMASK52026-04-06
10192253071412CARDINAL HEALTHCardinal Health 200, LLCAMMASK42026-03-23
10192253071429CARDINAL HEALTHCardinal Health 200, LLCAXLMASK62026-03-23
10192253071436CARDINAL HEALTHCardinal Health 200, LLCCHIMASK32026-03-23
10192253071443CARDINAL HEALTHCardinal Health 200, LLCINFMASK12026-03-23
10192253071450CARDINAL HEALTHCardinal Health 200, LLCNEOMASK02026-03-23
10192253071467CARDINAL HEALTHCardinal Health 200, LLCTODMASK22026-03-23
04719874951085Create BiotechCREATE BIOTECH CO., LTD.007-002-0002026-07-21
04719874951092Create BiotechCREATE BIOTECH CO., LTD.007-002-0012026-07-21
04719874952204Create BiotechCREATE BIOTECH CO., LTD.012-001-0052026-07-21
04719874958657Create BiotechCREATE BIOTECH CO., LTD.007-002-000XE2026-07-21
04719874958664Create BiotechCREATE BIOTECH CO., LTD.007-002-000E2026-07-21
14026704664983HUDSON RCITELEFLEX INCORPORATEDIPN0396762026-06-24
14026704664990HUDSON RCITELEFLEX INCORPORATEDIPN0396772026-06-24
14026704665003HUDSON RCITELEFLEX INCORPORATEDIPN0396782026-06-24
14026704665027HUDSON RCITELEFLEX INCORPORATEDIPN0396802026-06-24
14026704665034HUDSON RCITELEFLEX INCORPORATEDIPN0396812026-06-24
14026704665164HUDSON RCITELEFLEX INCORPORATEDIPN0396942026-06-24
14026704665171HUDSON RCITELEFLEX INCORPORATEDIPN0396952026-06-24
14026704665195HUDSON RCITELEFLEX INCORPORATEDIPN0396972026-06-24
14026704665201HUDSON RCITELEFLEX INCORPORATEDIPN0396982026-06-24
05030267156177ECONOMY, ANAESTHETIC FACE MASK, SIZE 0, NEONATE, NO HOOK RING, 15MIntersurgical Incorporated15111112026-06-10
05030267156184ECONOMY, ANAESTHETIC FACE MASK, SIZE 1, INFANT, NO HOOK RING, 15MIntersurgical Incorporated15121112026-06-10
05030267156191ECONOMY, ANAESTHETIC FACE MASK, SIZE 2, PAEDIATRIC, NO HOOK RING, 22FIntersurgical Incorporated15131112026-06-10
05030267156207ECONOMY, ANAESTHETIC FACE MASK, SIZE 3, SMALL ADULT, NO HOOK RING, 22FIntersurgical Incorporated15141112026-06-10
05030267156214ECONOMY, ANAESTHETIC FACE MASK, SIZE 4, MEDIUM ADULT, NO HOOK RING, 22FIntersurgical Incorporated15151112026-06-10
05030267156221ECONOMY, ANAESTHETIC FACE MASK, SIZE 5, LARGE ADULT, NO HOOK RING, 22FIntersurgical Incorporated15161112026-06-10
05030267156238ECONOMY, ANAESTHETIC FACE MASK, SIZE 6, EXTRA LARGE ADULT, NO HOOK RING, 22FIntersurgical Incorporated15171112026-06-10
10888277420496MEDLINEMEDLINE INDUSTRIES, INC.DYNJAAMASK32C2021-07-03
00612649184746King MaskAmbu A/S10122022-12-08
00612649184777King MaskAmbu A/S10222022-12-08
00612649184791King MaskAmbu A/S10322022-12-08
00612649184845King MaskAmbu A/S10452023-01-14
00612649184869King MaskAmbu A/S10552023-01-14
00612649184890King MaskAmbu A/S10652023-01-14
00612649184906King MaskAmbu A/S10752023-01-14