FDA.reportPublic FDA data

F&P OptiPAP Junior

Primary DI
09420012479105
Brand
F&P OptiPAP Junior
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
OPTIPAPC1724
Catalog number
OPTIPAPC1724
Device description
OptiPAP Junior Chinstrap 17-24cm
Published
2026-01-23
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
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
09420012479112PackageGS110In Commercial Distribution
09420012479105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012479112094200124791129420012479112
09420012479105094200124791059420012479105

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP chin strap, single-useA non-latex device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) therapy using a nasal mask or cannula, to control mouth air leaks by gently holding the mouth closed. It is available in sizes appropriate for neonatal/infant to adult patients. 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

Contacts#

Phone, Email table
PhoneEmail
1803 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704929204GIBECKTELEFLEX INCORPORATEDBZO2026-08-01
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04719874951139Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874951146Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874957483Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874957919Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959128Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959487Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959494Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959500Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959517Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959524Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
09420012402691Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
09420012433756Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
10197344011346HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011353HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011377HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
09420012479129F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479143F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479167F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
10889483225653AirLife™SUNMED, LLCBZO2025-12-19
09420012414885AdaptorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2025-10-07
14026704929099GIBECKTELEFLEX INCORPORATEDBZO2025-07-30
14026704660978HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-07
10889483570555AirLife™AIRLIFEBZO2025-03-27
10889483571675AirLife™AIRLIFEBZO2025-03-27
10889483571682AirLife™AIRLIFEBZO2025-03-27
10889483571699AirLife™AIRLIFEBZO2025-03-27