FDA.reportPublic FDA data

F&P OptiPAP Junior

Primary DI
09420012479341
Brand
F&P OptiPAP Junior
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
OPTIPAPML
Catalog number
OPTIPAPML
Device description
OptiPAP Junior Nasal Mask L
Published
2026-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
09420012479358PackageGS110In Commercial Distribution
09420012479341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012479358094200124793589420012479358
09420012479341094200124793419420012479341

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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

Contacts#

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

Regulatory Flags#

DUNS number
590153276
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
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
09420012479273F&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