BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Fisher and Paykel Healthcare

DI: 09420012418265 · Model: HC406A · 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: Fisher and Paykel Healthcare
Primary DI: 09420012418265
Version / Model: HC406A
Catalog Number: HC406A
Company Name: FISHER & PAYKEL HEALTHCARE LIMITED
Labeler DUNS: 590153276
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2022-08-02
Public Version: 2
Public Version Date: 2025-06-09
Public Version Status: Update
Public Device Record Key: a3b4ff34-317f-47d7-a91a-dce1860434a5
Distribution End Date: 2024-09-11

Device Description

FlexiFit 406 Petite Nasal 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: Yes
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
BYG	Mask, Oxygen	Anesthesiology	868.5580	1

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	09420012429179	GS1	PACK	10	Not in Commercial Distribution	2024-09-11
Primary	09420012418265	GS1

Customer Contacts

Phone: 1800 446 3908
Email: [email protected]

Storage Conditions

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