BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

F&P Optiflow

DI: 09420012480729 · Model: AA484J · FISHER & PAYKEL HEALTHCARE LIMITED

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: F&P Optiflow
Primary DI: 09420012480729
Version / Model: AA484J
Catalog Number: AA484J
Company Name: FISHER & PAYKEL HEALTHCARE LIMITED
Labeler DUNS: 590153276
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-11-07
Public Version: 1
Public Version Date: 2025-11-17
Public Version Status: New
Public Device Record Key: b1728295-3cb6-4409-a529-feca14cc242a

Device Description

F&P 820 Optiflow Oxygen Kit

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: Yes
MRI Safety: MR Unsafe
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
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	868.5450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65351	Humidified oxygen administration set	A collection of consumable devices designed to work together to deliver humidified pure oxygen (O2) or an O2 enriched gas to a mask or nasal cannula during oxygen administration to a patient (e.g., oxygen therapy, anaesthesia). It includes oxygen administration tubing (inspiratory line, dryline) which includes an electronic component (e.g., temperature sensor, heating wire), an inspiratory line humidification chamber, and may include a water bag. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09420012480736	GS1	PACK	10	In Commercial Distribution
Primary	09420012480729	GS1

Customer Contacts

Phone: 1800 446 3908
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211096	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -10 – 50 Degrees Celsius