FDA.reportPublic FDA data

AeroShield CPR Mask

Primary DI
09341394005242
Brand
AeroShield CPR Mask
Company
AERO HEALTHCARE (US), LLC
Model
AM01BUS
Catalog number
AM01BUS
Device description
CPR Mask
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KGBMask, Oxygen, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGBMask, Oxygen, Non-RebreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09341394005242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09341394005242093413940052429341394005242

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mask, single-use"A flexible, form-shaped device that is placed over a patient's mouth to administer ""mouth-to-mask"" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace ""mouth-to-mouth"" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device."

Regulatory Flags#

DUNS number
008186174
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09341394027183AeroShield CPR Face ShieldAFS001USAFS001US2026-04-02
09341394009158SUREFILLAKP01AKP012023-12-08
09341394009172SUREFILLAKB10WAKB10W2023-12-08
09341394009189SUREFILLAKB25WAKB25W2023-12-08
09341394009196SUREFILLAKB50WAKB50W2023-12-08
09341394009219SUREFILLAK75EWNAK75EWN2023-12-08
09341394009226SUREFILLAK10TAK10T2023-12-08
09341394009264SUREFILLAK25ATAK25AT2023-12-08
09341394009288SUREFILLAK25AWAK25AW2023-12-08
09341394009295SUREFILLAK25AVAK25AV2023-12-08
09341394009301SUREFILLAK25ANRAK25ANR2023-12-08
09341394009318SUREFILLAK50ATAK50AT2023-12-08
09341394009332SUREFILLAK50AWAK50AW2023-12-08
09341394009349SUREFILLAK50AVAK50AV2023-12-08
09341394009356SUREFILLAK50ANRAK50ANR2023-12-08
09341394009387SUREFILLAK50BWAK50BW2023-12-08
09341394009400SUREFILLAK50BNRAK50BNR2023-12-08
09341394011427CUSTOMAKPEI01-282AKPEI01-2822023-12-08
09341394011434CUSTOMAKPBT01-282AKPBT01-2822023-12-08
09341394011441CUSTOMAKPCS01-282AKPCS01-2822023-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923980102776N/AGaleMed Xiamen Co., Ltd.KGB2026-09-22
06923980102783N/AGaleMed Xiamen Co., Ltd.KGB2026-09-22
06923980106026N/AGaleMed Xiamen Co., Ltd.KGB2026-09-22
04719874950989Create BiotechCREATE BIOTECH CO., LTD.KGB2026-07-21
09341394027183AeroShield CPR Face ShieldAERO HEALTHCARE (US), LLCKGB2026-04-02
10197344009602HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344009619HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011476HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011483HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011506HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344011810HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
10197344042180HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
008171360277227450 RV2 MASKHANS RUDOLPH, INC.KGB2025-10-16
07045432118124Pocket Mask, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118223Pocket Mask, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432119145Pocket Mask, HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-08-27
07045432118131Pocket Mask, PB (EN)Laerdal Medical ASKGB2025-08-25
07045432119183Pocket Mask, HC White Private LabelLaerdal Medical ASKGB2025-08-25
07045432119206Pocket Mask, SP Black Private LabelLaerdal Medical ASKGB2025-08-25
07045432119220Pocket Mask, SP Camo Private LabelLaerdal Medical ASKGB2025-08-25
07045432119152Pocket Mask O2, PB (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119169Pocket Mask O2, SP Blue (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119176Pocket Mask O2,HC Yellow (DE FR ES IT EN)Laerdal Medical ASKGB2025-07-29
07045432119190Pocket Mask O2, HC White Private LabelLaerdal Medical ASKGB2025-07-29
07045432119213Pocket Mask O2, SP Black Private LabelLaerdal Medical ASKGB2025-07-29
07045432119237Pocket Mask O2, SP Camo Private LabelLaerdal Medical ASKGB2025-07-29
00840117345232Resp-O2 O2 Non-Rebreather Elongated MaskDynarex CorporationKGB2025-05-30
00840117345249Resp-O2 O2 Non-Rebreather Elongated MaskDynarex CorporationKGB2025-05-30
00840117345256Resp-O2 O2 Non-Rebreather Elongated MaskDynarex CorporationKGB2025-05-30
00840117345263Resp-O2 O2 Non-Rebreather Standard MaskDynarex CorporationKGB2025-05-30