FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012400413
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
HC150JHU
Catalog number
HC150JHU
Device description
Heated Respiratory Humidifier 115V-EN/FR/S
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K003973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003973000RESPIRATORY HUMIDIFIER, MODEL HC150Fisher & Paykel Healthcare, Ltd.2001-06-01BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012400413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012400413094200124004139420012400413

GMDN Terms#

Term, Definition table
TermDefinition
Heated respiratory humidifierA mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1800 446 3908Customer.CareUSA@fphcare.com

Regulatory Flags#

DUNS number
590153276
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
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