Fisher & Paykel Healthcare

Basic Information

• Brand Name: Fisher & Paykel Healthcare
• Primary DI: 09420012445483
• Version / Model: BC3780-20
• Catalog Number: BC3780-20
• Company Name: FISHER & PAYKEL HEALTHCARE LIMITED
• Labeler DUNS: 590153276
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-02
• Public Version: 1
• Public Version Date: 2022-08-10
• Public Version Status: New
• Public Device Record Key: f3b75227-1555-4054-b7b2-05f11e252cb7

Device Description

Pediatric Oxygen Therapy Nasal Cannula

Device Characteristics

• Single Use: Yes
• 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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAT	Cannula, Nasal, Oxygen	Anesthesiology	868.5340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35201	Nasal oxygen cannula, basic	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09420012445483	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 50 Degrees Celsius