FDA.reportPublic FDA data

Anaesthesia face mask, reusable

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 reusable device.
GUDID devices
236
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816711024910SILHOUETTE 2,ACCESSORY PackagePARKER-HANNIFIN CORPORATIONSIL-ADPT-PKG2024-07-11
04250105601534n.a.VBM Medizintechnik GmbH35-60-0002020-08-25
04250105601541n.a.VBM Medizintechnik GmbH35-60-0012020-08-25
04250105601558n.a.VBM Medizintechnik GmbH35-60-0022020-08-25
04250105601565n.a.VBM Medizintechnik GmbH35-60-0032020-08-25
04250105629637Hook RingVBM Medizintechnik GmbH88-60-2662023-01-31
04710810100482Venti.PlusGALEMED CORPORATIONH025-M2015-09-24
04710810100499Venti.PlusGALEMED CORPORATIONH050-M2015-09-24
04710810100505Venti.PlusGALEMED CORPORATIONH100-M2015-09-24
04710810117374Venti.PlusGALEMED CORPORATIONH0252015-09-24
04710810117381Venti.Plus GALEMED CORPORATIONH0502015-09-24
04710810117398Venti.PlusGALEMED CORPORATIONH1002015-09-24
05055788777205Anesthesia Face Mask Silicone Reusable Neonatal Size 0 (038-53-440SILeaGE)FLEXICARE MEDICAL LIMITED2106570-0112020-06-17
05055788777281Anesthesia Face Mask Silicone Reusable Small Child Size 1 (038-52-430SILeaGE)FLEXICARE MEDICAL LIMITED2106570-0192020-06-17
05055788777298Anesthesia Face Mask Silicone Reusable Medium Child Size 2 (038-52-420SILeaGE)FLEXICARE MEDICAL LIMITED2106570-0202020-06-17
05055788777304Anesthesia Face Mask Silicone Reusable Large Child Size 3 (038-52-415SILeaGE)FLEXICARE MEDICAL LIMITED2106570-0212020-06-17
05055788777311Anesthesia Face Mask Silicone Reusable Adult Size 4 (038-51-410SILeaGE)FLEXICARE MEDICAL LIMITED2106570-0222020-06-17
05055788777328Anesthesia Face Mask Silicone Reusable Large Adult Size 5 (038-51-400SILeaGE)FLEXICARE MEDICAL LIMITED2106570-0232020-06-17
05055788777380Anesthesia Face Mask Silicone Reusable Neonatal Size 0 (038-53-440SILGE)FLEXICARE MEDICAL LIMITED2106570-0292020-06-17
05055788777397Anesthesia Face Mask Silicone Reusable Small Child Size 1 (038-52-430SILGE)AnesFLEXICARE MEDICAL LIMITED2106570-0302020-06-17
05055788777403Anesthesia Face Mask Silicone Reusable Medium Child Size 2 (038-52-420SILGE)FLEXICARE MEDICAL LIMITED2106570-0312020-06-17
05055788777410Anesthesia Face Mask Silicone Reusable Large Child Size 3 (038-52-415SILGE)FLEXICARE MEDICAL LIMITED2106570-0322020-06-17
05055788777427Anesthesia Face Mask Silicone Reusable Adult Size 4 (038-51-410SILGE)FLEXICARE MEDICAL LIMITED2106570-0332020-06-17
05055788777434Anesthesia Face Mask Silicone Reusable Large Adult Size 5 (038-51-400SILGE)FLEXICARE MEDICAL LIMITED2106570-0342020-06-17
06923980100550AmbuGaleMed Xiamen Co., Ltd.XAM00012025-05-30
06923980100567AmbuGaleMed Xiamen Co., Ltd.XAM00022025-05-30
06923980100574AmbuGaleMed Xiamen Co., Ltd.XAM00032025-05-30
06923980100581AmbuGaleMed Xiamen Co., Ltd.XAM00042025-05-30
06923980100598AmbuGaleMed Xiamen Co., Ltd.XAM00052025-05-30
06923980100604AmbuGaleMed Xiamen Co., Ltd.XAM00062025-05-30
07325710002001Anest mask reuse,size 3 with MAQUETMaquet Critical Care AB66945752015-10-30
07325710002049Anest mask reuse,size 4 with MAQUETMaquet Critical Care AB66945772015-10-30
07325710002070NIV Mask (L) reuse,2 ports,MAQUETMaquet Critical Care AB66945872015-12-10
07325710002094NIV Mask (M) reuse,2 ports,MAQUETMaquet Critical Care AB66945852015-11-27
07325710002179NIV Mask (S) reuse,2 ports,MAQUETMaquet Critical Care AB66945822015-11-27
07325710002360Anest mask reuse,size 0 with MAQUETMaquet Critical Care AB66945672015-10-30
07325710002407Anest mask reuse,size 2 with MAQUETMaquet Critical Care AB66945722015-10-30
07325710002414Anest mask reuse,size 1 with MAQUETMaquet Critical Care AB66945702015-10-30
07325710002445Anest mask reuse,size 5 with MAQUETMaquet Critical Care AB66945802015-10-30
07540195010017O-TwoO-Two Medical Technologies Inc02FM49992019-10-16
07540195010031O-TwoO-Two Medical Technologies Inc02FM50012019-10-16
07540195010109O-TwoO-Two Medical Technologies Inc02FM50972019-10-16
07540195010116O-TwoO-Two Medical Technologies Inc02FM50982019-10-16
07540195010123O-TwoO-Two Medical Technologies Inc02FM50992019-10-16
07540195010147O-TwoO-Two Medical Technologies Inc02FM51012019-10-16
07540195010154O-TwoO-Two Medical Technologies Inc02FM51022019-10-16
10192253011036KangarooCardinal Health 200, LLC8884700108E2024-03-25
10884521583085KangarooCardinal Health, Inc.84065E2017-07-24
10884521583092KangarooCardinal Health, Inc.8884700108E2017-07-25
14250105628507n.a.VBM Medizintechnik GmbH88-11-0002020-08-25
14250105628514n.a.VBM Medizintechnik GmbH88-11-0012020-08-25
14250105628521n.a.VBM Medizintechnik GmbH88-11-0022020-08-25
14250105628583n.a.VBM Medizintechnik GmbH88-60-2662020-08-04
14250105629580Bi-MaskVBM Medizintechnik GmbH35-65-2222023-01-31
14250105629597Bi-MaskVBM Medizintechnik GmbH35-65-2232023-01-31
14250105629603Bi-MaskVBM Medizintechnik GmbH35-65-2242023-01-31
14250105629610Bi-MaskVBM Medizintechnik GmbH35-65-2252023-01-31
14250105629627Bi-MaskVBM Medizintechnik GmbH35-65-2262023-01-31
14250105630524Paediatric Mask; NewbornVBM Medizintechnik GmbH88-11-0002025-04-25
14250105630531Paediatric Mask; InfantVBM Medizintechnik GmbH88-11-0012025-04-25
14250105630548Paediatric Mask; ChildVBM Medizintechnik GmbH88-11-0022025-04-25
20884521134710NACovidien LPY-101400-002016-09-24
20884521134727Puritan BennettCovidien LPY-101400-012016-09-24
20884521134789Puritan BennettCovidien LPY-101976-002018-08-19
20884521134819Puritan BennettCovidien LPY-102616-002016-09-24
20884521135076Puritan BennettCovidien LPY-103075-00A2016-09-24
24026704017809RUSCHTELEFLEX INCORPORATEDIPN0425602018-09-15
24026704017816RUSCHTELEFLEX INCORPORATEDIPN0425612018-09-15
24026704017823RUSCHTELEFLEX INCORPORATEDIPN0425622018-09-15
24026704017830RUSCHTELEFLEX INCORPORATEDIPN0425632018-09-15
00816711024958PORTER,MED BR CIR,6FT,20PCKPARKER-HANNIFIN CORPORATIONDMC-12-62025-09-17
00816711024965PORTER,MED BR CIR,10FT,20PCKPARKER-HANNIFIN CORPORATIONDMC-12-102025-09-17
46923980100558AmbuGaleMed Xiamen Co., Ltd.XAM00012025-05-30
46923980100565AmbuGaleMed Xiamen Co., Ltd.XAM00022025-05-30
46923980100572AmbuGaleMed Xiamen Co., Ltd.XAM00032025-05-30
46923980100589AmbuGaleMed Xiamen Co., Ltd.XAM00042025-05-30
46923980100596AmbuGaleMed Xiamen Co., Ltd.XAM00052025-05-30
46923980100602AmbuGaleMed Xiamen Co., Ltd.XAM00062025-05-30
24250105630521Paediatric Mask; NewbornVBM Medizintechnik GmbH88-11-0002025-04-25
24250105630538Paediatric Mask; InfantVBM Medizintechnik GmbH88-11-0012025-04-25