FDA.reportPublic FDA data

Bonhawa Respiratory Humidifier

Primary DI
00850057298000
Brand
Bonhawa Respiratory Humidifier
Company
Telesair, Inc.
Model
RHFG303
Published
2025-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223863000BONHAWA Respiratory HumidifierTelesair, Inc.2023-10-13BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850057298000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057298000008500572980008500572980000850057298000

GMDN Terms#

Term, Definition table
TermDefinition
Professional high-flow respiratory unit, humidifying, manualAn electrically-powered device designed to deliver high-flow (exceeding peak inspiratory flow) heated and humidified ambient air or air/oxygen, at a manually set oxygen concentration (FiO2), to a spontaneously breathing patient. It is intended for use by a healthcare provider as part of noninvasive ventilation (NIV), in a peri-anaesthesia environment, or for a patient experiencing a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD)]. It typically consists of a gas flow generator, a heating element, and humidification chamber.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117854209
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009312234Bonhawa Air FilterAF2025-03-14
00860009312265Adult Nasal Cannula, Small ENC032025-03-12
00860009312272Adult Nasal Cannula, MediumENC022025-03-12
00860009312289Adult Nasal Cannula, LargeENC012025-03-12
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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