FDA.reportPublic FDA data

Airo™ CPAP Mask Liners

Primary DI
10850054813289
Brand
Airo™ CPAP Mask Liners
Company
Athfar 828 Inc
Model
SMPL-AL-100
Device description
Sample - Airo™ CPAP Mask Liners - Box of 100 - Large
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850054813289PrimaryGS10
00850054813282Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005481328910850054813289
00850054813282008500548132828500548132820850054813282

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose medical fibre paddingA roll, sheet or preformed shape of synthetic (e.g., polyester, polypropylene) or natural (e.g., cotton) fibre intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit350 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
(231) 598-9377customercare@athfar828.com

Regulatory Flags#

DUNS number
126152023
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850054813203Airo™ CPAP Mask LinersSMPL-AS-1002023-09-28
10850054813241Airo™ CPAP Mask LinersSMPL-AM-1002023-09-28
20850054813200Airo™ CPAP Mask LinersSMPL-AS-502023-09-28
20850054813248Airo™ CPAP Mask Liners SMPL-AM-502023-09-28
20850054813286Airo™ CPAP Mask Liners SMPL-AL-502023-09-28
30850054813207Airo™ CPAP Mask LinersSMPL-AS-252023-09-28
30850054813245Airo™ CPAP Mask LinersSMPL-AM-252023-09-28
30850054813283Airo™ CPAP Mask LinersSMPL-AL-252023-09-28
00850054813206Airo™ CPAP Mask LinersSMPL-AS-252023-09-28
00850054813244Airo™ CPAP Mask LinersSMPL-AM-252023-09-28
00850054813282Airo™ CPAP Mask LinersSMPL-AL-252023-09-28
10850054813098Airo™ CPAP Mask LinersSMPL-AS-100SMPL-AS-1002023-09-12
10850054813104Airo™ CPAP Mask LinersSMPL-AM-100SMPL-AM-1002023-09-12
10850054813111Airo™ CPAP Mask LinersSMPL-AL-100SMPL-AL-1002023-09-12
20850054813095Airo™ CPAP Mask LinersSMPL-AS-50SMPL-AS-502023-09-12
20850054813101Airo™ CPAP Mask LinersSMPL-AM-50SMPL-AM-502023-09-12
20850054813118Airo™ CPAP Mask LinersSMPL-AL-50SMPL-AL-502023-09-12
30850054813092Airo™ CPAP Mask LinersSMPL-AS-25SMPL-AS-252023-09-12
30850054813108Airo™ CPAP Mask LinersSMPL-AM-25SMPL-AM-252023-09-12
30850054813115 Airo™ CPAP Mask LinersSMPL-AL-25SMPL-AL-252023-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10814707025023CygnusASPEN SURGICAL PRODUCTS, INC.FRL2026-04-10
10850018327982MHMazza Healthcare LLCFRL2026-04-09
16931918102054HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918103969HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918107936HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918100913HALYARDGRI Medical & Electronic Technology Co., Ltd.FRL2025-09-17
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-08-06
10653160341628CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFRL2025-07-06
10197106935132CARDINAL HEALTHCardinal Health 200, LLCFRL2025-02-24
10810178830135Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830142Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830159Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830166Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830173Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830180Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10653160382928MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-01-15
10193489009460REMEDYMEDLINE INDUSTRIES, INC.FRL2024-10-24
10193489012521MEDLINEMEDLINE INDUSTRIES, INC.FRL2024-10-24
10850049784402SURGYCOSurgyco LLCFRL2023-12-15
10850049784419SURGYCOSurgyco LLCFRL2023-12-15
10810132041843HCSConcordance Healthcare Solutions LLCFRL2023-10-16
10884389108949MedlineMEDLINE INDUSTRIES, INC.FRL2023-10-12
10850054813203Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-28
10850054813241Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-28
10850054813296Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813302Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813319Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813098Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12
10850054813104Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12
10850054813111Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12