F&P OptiPAP Junior

Basic Information

• Brand Name: F&P OptiPAP Junior
• Primary DI: 09420012479204
• Version / Model: OPTIPAPB2026
• Catalog Number: OPTIPAPB2026
• Company Name: FISHER & PAYKEL HEALTHCARE LIMITED
• Labeler DUNS: 590153276
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-20
• Public Version: 1
• Public Version Date: 2026-01-28
• Public Version Status: New
• Public Device Record Key: ca71d45d-68af-4b6b-bb69-63cf31b3128f

Device Description

OptiPAP Junior Bonnet Kit 20-26cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SGR	Noninvasive Positive Airway Pressure System, Facility Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65875	Neonatal CPAP nasal mask holder	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09420012479211	GS1	PACK	10	In Commercial Distribution
Primary	09420012479204	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20-26CM

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 14 – 122 Degrees Fahrenheit