Somnera System Nasal Mask

Basic Information

• Brand Name: Somnera System Nasal Mask
• Primary DI: 30810045450170
• Version / Model: 94392
• Catalog Number: 94392
• Company Name: FRESCA MEDICAL, INC.
• Labeler DUNS: 068329904
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-12-29
• Public Version: 1
• Public Version Date: 2021-01-06
• Public Version Status: New
• Public Device Record Key: 4af10124-40d5-4bd4-8620-c6548faf2b36

Device Description

A positive airway pressure system for the treatment of obstructive sleep apnea. System consists of an airflow generator, mask, headgear, valve and hose.

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: Yes
• 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
QBY	Positive Airway Pressure System	Anesthesiology	868.5273	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60711	Home CPAP unit	A portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30810045450170	GS1
Unit of Use	00810045450179	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K200698	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity