Fisher & Paykel Healthcare

Basic Information

• Brand Name: Fisher & Paykel Healthcare
• Primary DI: 09420012428752
• Version / Model: HC482SL
• Catalog Number: HC482SL
• Company Name: FISHER & PAYKEL HEALTHCARE LIMITED
• Labeler DUNS: 590153276
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 2f7b4d7a-5da6-46cf-9045-6dfa88557456

Device Description

OPUS Nasal Pillows Mask for CPAP or Bi-level ventilation

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
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57815	CPAP/BPAP nasal mask, reusable	A flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09420012420145	GS1	Pack	10	In Commercial Distribution
Primary	09420012428752	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063036	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius