FDA.reportPublic FDA data

Airo™ CPAP Mask Liners

Primary DI
00850054813282
Brand
Airo™ CPAP Mask Liners
Company
Athfar 828 Inc
Model
SMPL-AL-25
Device description
Sample - Airo™ CPAP Mask Liners - Box of 25 - Large
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
20850054813286PrimaryGS10
30850054813283PrimaryGS10
00850054813282Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005481328910850054813289
2085005481328620850054813286
3085005481328330850054813283
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
126152023
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10850054813289Airo™ CPAP Mask LinersSMPL-AL-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
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
10850054813289Airo™ 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