iNAP

Basic Information

• Brand Name: iNAP
• Primary DI: 04719878320009
• Version / Model: 91000-07
• Catalog Number: 91000-07
• Company Name: SOMNICS, INC.
• Labeler DUNS: 657169335
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 1
• Public Version Date: 2020-10-01
• Public Version Status: New
• Public Device Record Key: 786d8ae7-3ac3-410a-a2c9-d497bad49f6b

Device Description

iNAP One sleep therapy system whole set package

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
OZR	Intraoral Pressure Gradient Device	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65078	Intraoral negative-pressure sleep apnoea unit	An electrically-powered device intended for home management of obstructive sleep apnoea (OSA) by using low, negative air pressure in the mouth to pull the soft palate and tongue forward to increase the patency of the pharynx; this repositioning obstructs oral breathing while allowing nasal breathing. It consists of a control unit containing a pump and sensor(s), to detect and adjust air pressure within the oral cavity, connected to a specially designed mouthpiece; it may in addition include associated items (e.g., saliva container, absorbent pad). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719878320009	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193460	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 760 – 1060 millibar
• Type: Storage Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius