FDA.report

Airo™ CPAP Mask Liners

Primary DI
00850054813114
Brand
Airo™ CPAP Mask Liners
Company
Athfar 828 Inc
Model
SMPL-AL-25
Catalog number
SMPL-AL-25
Device description
Sample - Airo™ CPAP Mask Liners - Box of 25 - Large
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

Related Records

Contact Domains

Product Codes

CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10850054813111PrimaryGS10
20850054813118PrimaryGS10
30850054813115PrimaryGS10
00850054813114Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005481311110850054813111
2085005481311820850054813118
3085005481311530850054813115
00850054813114008500548131148500548131140850054813114

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit350 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

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 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
00850054813107Airo™ CPAP Mask LinersSMPL-AM-25SMPL-AM-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 DIBrandCompanyProduct codePublished
B090MT630MorTan ZIEN MEDICAL TECHNOLOGIES, INC.FRL2026-02-17
26931918139798AllesetGRI Medical & Electronic Technology Co., Ltd.FRL2026-02-09
06947052762262ourmedShandong Hengfa Hygienic Products Co., Ltd.FRL2025-12-30
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