FDA.reportPublic FDA data

ASP CUSHION FACE MASK

Primary DI
00840216100855
Brand
ASP CUSHION FACE MASK
Company
Asp Global, LLC
Model
ASPMAT121
Device description
Cushion Face Mask with Eye Tape, Disposable, Infant 1/EA
Published
2022-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BSJMask, Gas, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840216100852PackageGS130In Commercial Distribution
00840216100855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084021610085210840216100852
00840216100855008402161008558402161008550840216100855

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
080361159
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216108738ASP MEDICALFMT630V2020-10-21
00840216108943ASP MEDICALFMT7002020-10-21
00840216108967ASP MEDICALFMT7102020-10-21
00840216108974ASP MEDICALFMT6552020-10-21
00840216108998ASP MEDICALFMT645V2020-10-21
00840216109018ASP MEDICALFMT640V2020-10-21
00840216109025ASP MEDICALFMT635V2020-10-21
00840216110922ASP MEDICALFMT605HEART2022-02-09
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08
00840216120068ASP MEDICAL10382XL-ASP2022-08-08
00840216117600ASP MEDICAL1206BG22022-05-09
00840216118171ASP MEDICAL1207BG22022-05-09
00840216118188ASP MEDICAL1208BG22022-05-09
00840216118195ASP MEDICAL1206BG2B2022-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14026704665171HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665195HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665201HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
05030267156177ECONOMY, ANAESTHETIC FACE MASK, SIZE 0, NEONATE, NO HOOK RING, 15MIntersurgical IncorporatedBSJ2026-06-10
05030267156184ECONOMY, ANAESTHETIC FACE MASK, SIZE 1, INFANT, NO HOOK RING, 15MIntersurgical IncorporatedBSJ2026-06-10
05030267156191ECONOMY, ANAESTHETIC FACE MASK, SIZE 2, PAEDIATRIC, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
05030267156207ECONOMY, ANAESTHETIC FACE MASK, SIZE 3, SMALL ADULT, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
05030267156214ECONOMY, ANAESTHETIC FACE MASK, SIZE 4, MEDIUM ADULT, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
05030267156221ECONOMY, ANAESTHETIC FACE MASK, SIZE 5, LARGE ADULT, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
05030267156238ECONOMY, ANAESTHETIC FACE MASK, SIZE 6, EXTRA LARGE ADULT, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
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