FDA.report

Airo™ CPAP Mask Liners

Primary DI
00850054813091
Brand
Airo™ CPAP Mask Liners
Company
Athfar 828 Inc
Model
SMPL-AS-25
Catalog number
SMPL-AS-25
Device description
Sample - Airo™ CPAP Mask Liners - Box of 25 - Small
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
10850054813098PrimaryGS10
20850054813095PrimaryGS10
30850054813092PrimaryGS10
00850054813091Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005481309810850054813098
2085005481309520850054813095
3085005481309230850054813092
00850054813091008500548130918500548130910850054813091

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
00850054813107Airo™ CPAP Mask LinersSMPL-AM-25SMPL-AM-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

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