FDA.reportPublic FDA data

Bonhawa Air Filter

Primary DI
00860009312234
Brand
Bonhawa Air Filter
Company
Telesair, Inc.
Model
AF
Published
2025-03-14
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
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860009312231PackageGS130In Commercial Distribution
20860009312238PackageGS13In Commercial Distribution
00860009312234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000931223110860009312231
2086000931223820860009312238
00860009312234008600093122348600093122340860009312234

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP unit ambient air filter, reusableA non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It is typically a flat sheet or pad composed of tightly woven materials or foam intended to be installed over the air inlet of the CPAP/BPAP device to remove particulates/impurities; it is not intended to filter microbes. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117854209
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009312265Adult Nasal Cannula, Small ENC032025-03-12
00860009312272Adult Nasal Cannula, MediumENC022025-03-12
00860009312289Adult Nasal Cannula, LargeENC012025-03-12
00850057298000Bonhawa Respiratory HumidifierRHFG3032025-03-12
10860009312262Adult Nasal Cannula, Small ENC032025-03-12
10860009312279Adult Nasal Cannula, MediumENC022025-03-12
10860009312286Adult Nasal Cannula, LargeENC012025-03-12
00860009312296Heated Breathing SetHBCK012025-03-12

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Primary DI, Brand, Company table
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