FDA.reportPublic FDA data

Airo™ CPAP Mask Liners

Primary DI
20850054813316
Brand
Airo™ CPAP Mask Liners
Company
Athfar 828 Inc
Model
EVAL-AS-50
Catalog number
EVAL-AS-50
Device description
Evaluation Pack - Airo™ CPAP Mask Liners - Box of 50 - Small
Published
2023-09-20
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
FRLFiber, Medical, Absorbent

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850054813316PrimaryGS10
00850054813312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085005481331620850054813316
00850054813312008500548133128500548133120850054813312

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

Regulatory Flags#

DUNS number
126152023
Device count
50
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536925007BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925014BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925021BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925038BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925045BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925052BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925069BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925076BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925083BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925090BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925106BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925113BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925120BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925137BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925144BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925151BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925168BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
20197344219428MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219442MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219459MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219466MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219473MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219480MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219497MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219503MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219435MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-13
10814707025023CygnusASPEN SURGICAL PRODUCTS, INC.FRL2026-04-10
10850018327982MHMazza Healthcare LLCFRL2026-04-09
B090MT630MorTanZien Medical Technologies, LLCFRL2026-02-17
00858303003002SynterventionZien Medical Technologies, LLCFRL2025-09-25