FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012433756
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
BC402-05
Catalog number
BC402-05
Device description
Gas Supplyline two flowmeters
Published
2026-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012414007PackageGS15In Commercial Distribution
09420012433756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012414007094200124140079420012414007
09420012433756094200124337569420012433756

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory humidifier/pulmonary resuscitator gas supply tubingA length of thin, flexible, connection tube intended to conduct a gas [typically air, oxygen, nitric oxide (NO), and/or helium] from a breathing gas mixer and/or flowmeter to a respiratory humidifier and/or pulmonary resuscitator for subsequent inhalation. It is not made of a reinforced/thick material (i.e., not a hose), and does not connect directly with a Y-piece connector or a mask (i.e., not inspiratory/expiratory limb respiratory tubing). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
590153276
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09420012432070Fisher and Paykel HealthcareOPT542OPT5422022-08-02
09420012432087Fisher and Paykel HealthcareOPT544OPT5442022-08-02
09420012432094Fisher and Paykel HealthcareOPT546OPT5462022-08-02
09420012432100Fisher & Paykel HealthcareOPT570OPT5702023-07-06
09420012480729F&P OptiflowAA484JAA484J2025-11-07
09420012433831Fisher & Paykel HealthcareAA400SUAA400SU2016-09-08
09420012424808Fisher & Paykel HealthcareOPT870EOPT870E2023-07-06
09420012432148Fisher & Paykel HealthcareOPT870OPT8702023-07-06
09420012432162Fisher & Paykel HealthcareRT241RT2412022-08-02
09420012414557Fisher & Paykel Healthcare900MR441900MR4412022-08-02
09420012477477F&P OptiNIVONIV117AONIV117A2025-12-06
09420012477484F&P OptiNIVONIV117BONIV117B2025-12-06
09420012477491F&P OptiNIVONIV117CONIV117C2025-12-06
09420012480446F&P OptiNIVONIV117A-FONIV117A-F2025-12-06
09420012480460F&P OptiNIVONIV117B-FONIV117B-F2025-12-06
09420012480484F&P OptiNIVONIV117C-FONIV117C-F2025-12-06
09420012424815Fisher & Paykel HealthcareRT013ERT013E2022-08-02
09420012432155Fisher & Paykel HealthcareRT013RT0132022-08-02
09420012436047Fisher & Paykel HealthcareWJR210WJR2102026-04-14
09420012436061Fisher & Paykel HealthcareWJR212WJR2122026-04-14

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