FDA.reportPublic FDA data

Resuscitator face mask, reusable

Definition
A flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a reusable device.
GUDID devices
79
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05707480030439Silicone Face MaskAmbu A/S0003120002022-12-08
05707480030453Silicone Face MaskAmbu A/S0003150002022-12-08
05707480030460Silicone Face MaskAmbu A/S0003160002022-12-08
05707480030477Silicone Face MaskAmbu A/S0003170002022-12-08
05707480030484Silicone Face MaskAmbu A/S0003190002022-12-08
10641043506011Silicone Face MaskMERCURY ENTERPRISES, INC.10-506012018-01-01
10641043506028Silicone Face MaskMERCURY ENTERPRISES, INC.10-506022018-01-01
10641043506035Silicone Face MaskMERCURY ENTERPRISES, INC.10-506032018-01-01
10641043506042Silicone Face MaskMERCURY ENTERPRISES, INC.10-506042018-01-01
10641043506059Silicone Face MaskMERCURY ENTERPRISES, INC.10-506052018-01-01
10641043506073Silicone Face MaskMERCURY ENTERPRISES, INC.10-506072018-01-01
10641043506080Silicone Face MaskMERCURY ENTERPRISES, INC.10-506082018-01-01
10641043506097Silicone Face MaskMERCURY ENTERPRISES, INC.10-506092018-01-01
10641043506103Silicone Face MaskMERCURY ENTERPRISES, INC.10-506102018-01-01
10641043506110Silicone Face MaskMERCURY ENTERPRISES, INC.10-506112018-01-01
10641043506127Silicone Face MaskMERCURY ENTERPRISES, INC.10-506122018-01-01
24026704658842HUDSON RCITELEFLEX INCORPORATEDIPN0297552019-08-05
34026704615699HUDSON RCITELEFLEX INCORPORATEDIPN0493602019-08-05
34026704615705HUDSON RCITELEFLEX INCORPORATEDIPN0493612019-08-05
34026704615712HUDSON RCITELEFLEX INCORPORATEDIPN0493622019-08-05
34026704626343HUDSON RCITELEFLEX INCORPORATEDIPN0493632019-08-05
34026704626350HUDSON RCITELEFLEX INCORPORATEDIPN0493642019-08-05
06923980112690MindrayGaleMed Xiamen Co., Ltd.XMR01042026-05-26
06923980112645MindrayGaleMed Xiamen Co., Ltd.XMR00152026-05-25
06923980112652MindrayGaleMed Xiamen Co., Ltd.XMR00162026-05-25
06923980112669MindrayGaleMed Xiamen Co., Ltd.XMR00172026-05-25
06923980112706MindrayGaleMed Xiamen Co., Ltd.XMR00182026-05-25
06923980112713MindrayGaleMed Xiamen Co., Ltd.XMR00202026-05-25
07045432120462Laerdal Silicone MasksLaerdal Medical AS851500-12026-01-29
07045432120479Laerdal Silicone MasksLaerdal Medical AS851600-12026-01-29
07045432120486Laerdal Silicone MasksLaerdal Medical AS851700-1 2026-01-29
07045432120493Laerdal Silicone MasksLaerdal Medical AS860220-12026-01-29
07045432120509Laerdal Silicone MasksLaerdal Medical AS870220-12026-01-29
14026704658845HUDSON RCITELEFLEX INCORPORATEDIPN0297552019-08-05
00026072022269EMAllied Medical, LLCL595160-0502024-10-11
00026072022535EMAllied Medical, LLCL595060-0202024-10-11
00026072022559EMAllied Medical, LLCL595159-0012024-10-11
00026072022566EMAllied Medical, LLCL595160-0202024-10-11
05707480006601Silicone Face MaskAmbu A/S0003120002022-12-08
05707480006625Silicone Face MaskAmbu A/S0003150002022-12-08
05707480006632Silicone Face MaskAmbu A/S0003160002022-12-08
05707480006649Silicone Face MaskAmbu A/S0003170002022-12-08
05707480006656Silicone Face MaskAmbu A/S0003190002022-12-08
00816711024187INTL DEMAND VALVE ASSY-CENT.MXPARKER-HANNIFIN CORPORATION915050922023-12-06
07045432112269Newborn Mask - Size 0 Qty 1 - Snap DesignLaerdal Medical AS856156-12022-11-30
07045432112399Newborn Mask - Size 1 Qty 1 - Snap Design (US)Laerdal Medical AS856157-12022-11-30
14026704615695HUDSON RCITELEFLEX INCORPORATEDIPN0493602019-08-05
14026704615701HUDSON RCITELEFLEX INCORPORATEDIPN0493612019-08-05
14026704615718HUDSON RCITELEFLEX INCORPORATEDIPN0493622019-08-05
14026704626349HUDSON RCITELEFLEX INCORPORATEDIPN0493632019-08-05
14026704626356HUDSON RCITELEFLEX INCORPORATEDIPN0493642019-08-05
07045430012257LSR Silicone Mask No.00Laerdal Medical AS8515002020-10-28
07045430012264LSR Silicone Mask No.0/1Laerdal Medical AS8516002020-10-28
07045430012271LSR Silicone Mask No.2Laerdal Medical AS8517002020-10-28
07045430012387LSR Silicone Mask No. 3-4 w/ Multi-Func Mask CoverLaerdal Medical AS8602202020-10-28
07045430012530Adult Silicone Mask 4-5+ w/ Multi-Func Mask CoverLaerdal Medical AS8702202020-10-28
07045430012646Adult & Child Silicone Masks w/ Multi-Func Mask CoversLaerdal Medical AS8722202020-10-28
07045432033939Child Silicone Mask 3-4 w/o Multi-Func Mask CoverLaerdal Medical AS8602212020-10-28
07045432033946Adult Silicone Mask 4-5+ w/o Multi-Func Mask CoverLaerdal Medical AS8702212020-10-28
07045432087321Newborn Mask - Size 0 Qty 10 - Snap DesignLaerdal Medical AS846156012020-10-28
07045432087345Newborn Mask - Size 1 Qty 10 - Snap Design (US)Laerdal Medical AS846157012020-10-28
07045432092448Newborn Mask - Size 0 Qty 10 - Snap Design (US)Laerdal Medical ASLGH-846156012020-10-28
07045432092479Newborn Mask - Size 1 Qty 10 - Snap Design (US)Laerdal Medical ASLGH-846157012020-10-28
B00225000Rescuer Silicone Resuscitation Mask (#5 Adult)B.L.S. Systems Limited25002018-10-03
B00225050Rescuer Silicone Resuscitation Mask (#4 Adult)B.L.S. Systems Limited25052018-10-03
B00225100Rescuer Silicone Resuscitation Mask (#3 Child)B.L.S. Systems Limited25102018-10-03
B00225250Rescuer Silicone Resuscitation Mask (#2 Infant)B.L.S. Systems Limited25252018-10-03
B00225300Rescuer Silicone Resuscitation Mask (#1 Infant)B.L.S. Systems Limited25302018-10-03
B00225350Rescuer Silicone Resuscitation Mask (#0 Infant)B.L.S. Systems Limited25352018-10-03
04719872109020madaENTER MEDICAL CORPORATIONMada-14352016-03-07
04719872109044madaENTER MEDICAL CORPORATIONMada-14372016-03-07
04719872109365madaENTER MEDICAL CORPORATIONMada-14362016-03-07
04719872109372madaENTER MEDICAL CORPORATIONMada-1436NN2016-03-07
00814940020833FERNO2Spiracle TechnologyT50550-002017-04-12
00814940020840FERNO2Spiracle TechnologyT50550-012017-04-12
00814940020857FERNO2Spiracle TechnologyT50550-022017-04-12
00814940020864FERNO2Spiracle TechnologyT50550-032017-04-12
00814940020871FERNO2Spiracle TechnologyT50550-042017-04-12
00814940020888FERNO2Spiracle TechnologyT50550-052017-04-12