Fisher & Paykel Healthcare

Basic Information

• Brand Name: Fisher & Paykel Healthcare
• Primary DI: 09420012470737
• Version / Model: 900PT475
• Catalog Number: 900PT475
• Company Name: FISHER & PAYKEL HEALTHCARE LIMITED
• Labeler DUNS: 590153276
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-13
• Public Version: 1
• Public Version Date: 2023-09-21
• Public Version Status: New
• Public Device Record Key: 4332dbff-6d32-43d0-b72c-02f3330004cf

Device Description

Airvo 3 Suite Service Application

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: 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QAV	High Flow/High Velocity Humidified Oxygen Delivery Device	Anesthesiology	868.5454	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37331	Medical equipment inventory management/maintenance software	An application software program intended to be used to manage data pertaining to the use, maintenance and servicing of medical devices and equipment, namely relating to one or more of the following: device electronic registration, inventory management, device identifiers, maintenance and servicing, spare parts ordering, equipment assessment, renewal planning or authority auditing, onboarding, firmware updating, and device diagnostic data submission to the manufacturer. It may be referred to as a medical equipment management system (MEMS) and is typically used by a clinical engineering department.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09420012470737	GS1

Customer Contacts

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