Nasal Interface, 1PK

Basic Information

• Brand Name: Nasal Interface, 1PK
• Primary DI: 00817131020377
• Version / Model: RP-1009
• Catalog Number: RP-1009
• Company Name: INOGEN, INC.
• Labeler DUNS: 136729634
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-20
• Public Version: 1
• Public Version Date: 2020-03-30
• Public Version Status: New
• Public Device Record Key: d8284a4a-b690-488f-84ee-7e898563ea5d

Device Description

Nasal Interface, 1PK, RP-1009

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
ONZ	Mechanical Ventilator	Anesthesiology	868.5895	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
Primary	00817131020377	GS1

Premarket Submissions

Submission Number	Supplement Number
K152664	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity