FDA.reportPublic FDA data

Adult Elongated Non Re breather Mask

Primary DI
00709078008023
Brand
Adult Elongated Non Re breather Mask
Company
WESTMED, INC.
Model
3228-E
Device description
Adult Elongated Non Re breather Mask
Published
2019-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10709078008020PackageGS150In Commercial Distribution
00709078008023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800802010709078008020
00709078008023007090780080237090780080230709078008023

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Regulatory Flags#

DUNS number
092673953
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709078007781Composite Respiratory Kit07992019-10-18
00709078012693Septal-H Infant SizeCP-5500A2021-10-08
00709078012716Septal-H Pediatric SizeCP-5510A2021-10-08
00709078012990CapetteCP-42012021-06-25
00709078013003CapetteCP-42022021-06-25
00709078013010CapetteCP-42032021-06-25
00709078013027CapetteCP-44012021-06-25
00709078013034CapetteCP-44022021-06-25
00709078013041CapetteCP-44032021-06-25
00709078013058StrapetteCP-42042021-06-25
00709078013065StrapetteCP-42202021-06-25
00709078013072StrapetteCP-44042021-06-25
00709078013089StrapetteCP-44202021-06-25
00709078013096ChinstrapCP-51002021-06-25
00709078013102ChinstrapCP-52002021-06-25
00709078013119Septal-HCP-54002021-06-30
00709078013126Septal-HCP-54102021-06-30
00709078013133Septal-HCP-55002021-06-30
00709078013140Septal-HCP-55102021-06-30
00709078013157SavEarRT-61002021-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09341394005242AeroShield CPR MaskAERO HEALTHCARE (US), LLCKGB2026-04-21
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
20197344009609HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344009616HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011473HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011480HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011503HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344011817HUDSON RCIMEDLINE INDUSTRIES, INC.KGB2025-11-14
20197344042187HUDSON 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