F&P OptiPAP Junior OPTIPAPMXXS

GUDID 09420012479297

OptiPAP Junior Nasal Mask XXS

FISHER & PAYKEL HEALTHCARE LIMITED

CPAP/BPAP nasal mask, single-use

• Primary Device ID: 09420012479297
• NIH Device Record Key: 2772e886-17db-4859-8350-3dc8f6a47bed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: F&P OptiPAP Junior
• Version Model Number: OPTIPAPMXXS
• Catalog Number: OPTIPAPMXXS
• Company DUNS: 590153276
• Company Name: FISHER & PAYKEL HEALTHCARE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com
• Phone: 1800 446 3908
• Email: Customer.CareUSA@fphcare.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09420012479280 [Primary]
GS1	09420012479297 [Package]; Contains: 09420012479280; Package: PACK [10 Units]; In Commercial Distribution

FDA Product Code

• SGR: Noninvasive Positive Airway Pressure System, Facility Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-28
• Device Publish Date: 2026-01-20

On-Brand Devices [F&P OptiPAP Junior]

• 09420012479556: OptiPAP Junior FlexiTube
• 09420012479518: OptiPAP Junior Nasal Prongs XL
• 09420012479495: OptiPAP Junior Nasal Prongs L
• 09420012479471: OPTIPAPPM
• 09420012479457: OptiPAP Junior Nasal Prongs S
• 09420012479433: OptiPAP Junior Nasal Prongs XS
• 09420012479419: OptiPAP Junior Nasal Prongs XXS
• 09420012479396: OptiPAP Junior Nasal Mask S
• 09420012479372: OptiPAP Junior Nasal Mask XL
• 09420012479358: OptiPAP Junior Nasal Mask L
• 09420012479334: OptiPAP Junior Nasal Mask M
• 09420012479310: OptiPAP Junior Nasal Mask XS
• 09420012479297: OptiPAP Junior Nasal Mask XXS
• 09420012479273: OptiPAP Junior Bonnet Kit 34-45cm
• 09420012479259: OptiPAP Junior Bonnet Kit 29-36cm
• 09420012479235: OptiPAP Junior Bonnet Kit 24-31cm
• 09420012479211: OptiPAP Junior Bonnet Kit 20-26cm
• 09420012479198: OptiPAP Junior Bonnet Kit 17-22cm
• 09420012479174: OptiPAP Junior Chinstrap 36-45cm
• 09420012479150: OptiPAP Junior Chinstrap 29-37cm
• 09420012479136: OptiPAP Junior Chinstrap 23-30cm
• 09420012479112: OptiPAP Junior Chinstrap 17-24cm