FDA.reportPublic FDA data

Airo™ CPAP Mask Liners

Primary DI
00850054813107
Brand
Airo™ CPAP Mask Liners
Company
Athfar 828 Inc
Model
SMPL-AM-25
Catalog number
SMPL-AM-25
Device description
Sample - Airo™ CPAP Mask Liners - Box of 25 - Medium
Published
2023-09-12
Public version status
Update
Distribution status
Not 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
10850054813104PrimaryGS10
20850054813101PrimaryGS10
30850054813108PrimaryGS10
00850054813107Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005481310410850054813104
2085005481310120850054813101
3085005481310830850054813108
00850054813107008500548131078500548131070850054813107

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
00850054813206Airo™ CPAP Mask LinersSMPL-AS-252023-09-28
00850054813244Airo™ CPAP Mask LinersSMPL-AM-252023-09-28
00850054813282Airo™ CPAP Mask LinersSMPL-AL-252023-09-28
00850054813091Airo™ CPAP Mask LinersSMPL-AS-25SMPL-AS-252023-09-12
00850054813114 Airo™ CPAP Mask LinersSMPL-AL-25SMPL-AL-252023-09-12
00850054813336Airo™ CPAP Mask LinersAM-252023-09-20
00850054813350Airo™ CPAP Mask LinersAS-252023-09-20
00850054813343Airo™ CPAP Mask Liners AL-252023-09-20
00850054813299Airo™ CPAP Mask LinersEVAL-AL-100EVAL-AL-1002023-09-20
00850054813305Airo™ CPAP Mask LinersEVAL-AM-100EVAL-AM-1002023-09-20
00850054813312Airo™ CPAP Mask LinersEVAL-AS-100EVAL-AS-1002023-09-20
00850054813121Airo™ CPAP Mask LinersAS-25AS-252023-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B090MT630MorTan ZIEN MEDICAL TECHNOLOGIES, INC.FRL2026-02-17
26931918139798AllesetGRI Medical & Electronic Technology Co., Ltd.FRL2026-02-09
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00850067106012Austin Medical, IncAUSTIN MEDICALFRL2025-12-22
00850067106050Austin Medical, IncAUSTIN MEDICALFRL2025-12-22
00850067106067Austin Medical, IncAUSTIN MEDICALFRL2025-12-22
00859410006375SalimetricsSALIMETRICS, LLCFRL2025-12-10
26931918102051HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
26931918103966HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
26931918107933HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
10858303003009Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.FRL2025-09-25
10858303003016Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.FRL2025-09-25
10858303003030Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.FRL2025-09-25
10858303003047Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.FRL2025-09-25
26931918100910HALYARDGRI Medical & Electronic Technology Co., Ltd.FRL2025-09-17
26931918146857AllesetGRI Medical & Electronic Technology Co., Ltd.FRL2025-06-20
30888277653614MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-06-02
20613647027572FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FRL2025-04-30
20613647027589FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FRL2025-04-30
20613647027596FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FRL2025-04-30
20613647027602FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FRL2025-04-30
30193489003592MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-04-25
50197106935130CARDINAL HEALTHCardinal Health 200, LLCFRL2025-02-24
20810178830132Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830149Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830156Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830163Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830170Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830187Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
E2212248Sticky TimVOCO GmbHFRL2025-01-22