FISHER & PAYKEL HEALTHCARE

Basic Information

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Primary DI: 09420012420343
• Version / Model: RD020-01
• Catalog Number: 0W90
• Company Name: FISHER & PAYKEL HEALTHCARE LIMITED
• Labeler DUNS: 590153276
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-25
• Public Version: 4
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: 47639a70-84d3-49fc-8fbe-90c1c82669e3

Device Description

TEST LUNG NON LATEX

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: 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
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	868.5925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12408	Lung physical simulator	A mechanical device intended to simulate/mimic the human lung(s) by imitating its physical properties. This device, commonly known as a test lung, may be a simple ventilation bag filled with foam rubber, or a complicated device, usually mechanical, that can be adjusted to imitate, e.g., change in compliance, airway restrictions, lung perforation. It is intended to be used by a healthcare provider in a clinical setting for the purpose of, e.g., maintenance, testing, user control of a ventilator and for the education of clinical staff.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09420012420343	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K892885	000