FDA.reportPublic FDA data

F&P OptiPAP Junior

Primary DI
09420012479273
Brand
F&P OptiPAP Junior
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
OPTIPAPB3445
Catalog number
OPTIPAPB3445
Device description
OptiPAP Junior Bonnet Kit 34-45cm
Published
2026-01-20
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
SGRNoninvasive Positive Airway Pressure System, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SGRNoninvasive Positive Airway Pressure System, Facility UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012479273PackageGS110In Commercial Distribution
09420012479266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012479273094200124792739420012479273
09420012479266094200124792669420012479266

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal CPAP nasal mask holderA non-latex, head-worn device designed to be used during continuous positive airway pressure (CPAP) therapy to hold a CPAP nasal mask/cannula in place on a neonatal/infant patient. It is typically in the form of a band or bonnet; it is not a pull-tight mask strap with a buckle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit122 Degrees Fahrenheit

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
false
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
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
09420012474643F&P 850850A61J850A61J2026-04-13
09420012405890Fisher & Paykel Healthcare900HC031900HC0312026-04-08
09420012409690Fisher & Paykel Healthcare900RD302900RD3022026-04-08
09420012416728Fisher & Paykel Healthcare900HC033900HC0332026-04-08
09420012425911Fisher & Paykel HealthcareOPT31POPT31P2026-04-08
09420012425928Fisher & Paykel HealthcareOPT31NOPT31N2026-04-08
09420012430410Fisher & Paykel HealthcareRT205RT2052026-04-08
09420012449818Fisher & Paykel HealthcareRT331RT3312026-04-08
09420012429810FISHER & PAYKEL HEALTHCARE RT008RT0082015-09-25
09420012416810Fisher & Paykel HealthcareHC550JHUHC550JHU2016-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012479181F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479204F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479228F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479242F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479266F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479280F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479303F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479327F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479341F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479365F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479389F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479402F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479426F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479440F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479464F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479488F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479501F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479549F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479198F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479211F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479235F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479259F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479297F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479310F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479334F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479358F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479372F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479396F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479419F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20
09420012479433F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDSGR2026-01-20