FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012415226
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
BC331-05
Catalog number
BC331-05
Device description
Headgear Midline 40-45cm
Published
2022-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
09420012415226PackageGS15In Commercial Distribution
09420012432773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012415226094200124152269420012415226
09420012432773094200124327739420012432773

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, CPAPA semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to deliver oxygen (O2) to the patient and provide continuous positive airway pressure (CPAP) from the devices to which it is connected. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
590153276
Device count
1
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
true
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09420012429803FISHER & PAYKEL HEALTHCARERT0010T292015-09-25
09420012405913Fisher & Paykel Healthcare900MR011900MR0112026-03-23
09420012429810FISHER & PAYKEL HEALTHCARE RT0080T292015-09-25
09420012429940FISHER & PAYKEL HEALTHCARE900RD014-10900RD014-102015-09-25
09420012429957FISHER & PAYKEL HEALTHCARE900RD015-10900RD015-102015-09-25
09420012429964FISHER & PAYKEL HEALTHCARE900RD016-10900RD016-102015-09-25
09420012416582FISHER & PAYKEL HEALTHCARE900RD110900RD1102015-09-25
09420012430021FISHER & PAYKEL HEALTHCARERD1340-10RD1340-102015-09-25
09420012430038FISHER & PAYKEL HEALTHCARERD1341-102015-09-25
09420012430045FISHER & PAYKEL HEALTHCARERD1350-10RD1350-102015-09-25
09420012430052FISHER & PAYKEL HEALTHCARERD1351-10RD1351-102015-09-25
09420012430076FISHER & PAYKEL HEALTHCARERD1360-10RD1360-102015-09-25
09420012430083FISHER & PAYKEL HEALTHCARERD1361-10RD1361-102015-09-25
09420012430090FISHER & PAYKEL HEALTHCARERD1370-10RD1370-102015-09-25
09420012430106FISHER & PAYKEL HEALTHCARERD1371-10RD1371-102015-09-25
09420012430113FISHER & PAYKEL HEALTHCARERD803-10RD803-102015-09-25
09420012430120FISHER & PAYKEL HEALTHCARE RD804-100W902015-09-25
09420012430137FISHER & PAYKEL HEALTHCARE RD805-10RD805-102015-09-25
09420012430144FISHER & PAYKEL HEALTHCARE RD806-10RD806-102015-09-25
09420012430151FISHER & PAYKEL HEALTHCARE RD807-10RD807-102015-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923980112546MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-26
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06944904007465MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-25
06944904007472MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-25
20197344011343HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
20197344011350HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
20197344011374HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
44710810100329N/AGALEMED CORPORATIONBZO2026-03-05
44710810107311N/AGALEMED CORPORATIONBZO2026-03-04
04719894389189VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
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04719894389202VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
09420012479112F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479136F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479150F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479174F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
46923980106406N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
46923980106413N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
46923980106420N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
14719894389162VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-20
04719894389172VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-20
20889483225650AirLife™SUNMED, LLCBZO2025-12-19
44710810088405N/AGALEMED CORPORATIONBZO2025-12-18
14719894386314VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386321VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386338VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386345VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386352VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01