iNAP

Basic Information

• Brand Name: iNAP
• Primary DI: 04719878321532
• Version / Model: Starter Kit
• Company Name: SOMNICS, INC.
• Labeler DUNS: 657169335
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-05
• Public Version: 1
• Public Version Date: 2024-02-13
• Public Version Status: New
• Public Device Record Key: 8acb544e-dd05-43bc-9ad3-39a57fa086cb

Device Description

(1) iNAP One Sleep Therapy System [iNAP Console(R07-A) x1, Tubing Set x1, Saliva Container x1, Power Adapter x1, Oral Interface (Model: I07H) x1, DryPad x93]; (2) Nasal Dilator [ZEEBUD x1]

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
OZR	Intraoral Pressure Gradient Device	Dental	872.5570	2
LWF	Dilator, Nasal	Ear, Nose, Throat	874.3900	1

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
47607	Nasal breathing aid, internal, reusable	An internal device intended to improve breathing by decreasing nasal resistance, thus increasing nasal airflow. It is typically in the form of clip, constructed from metal or plastic, that is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella (fleshy external end of the nasal septum). The device provides temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or nasal congestion. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719878321532	GS1

Customer Contacts

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