iNAP 28001-07

GUDID 04719878320511

iNAP Muffler

SOMNICS, INC.

Intraoral negative-pressure sleep apnoea unit

• Primary Device ID: 04719878320511
• NIH Device Record Key: 30a2f98c-2f3b-4ea9-a703-90a65a7734be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iNAP
• Version Model Number: 28001-07
• Catalog Number: 28001-07
• Company DUNS: 657169335
• Company Name: SOMNICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-833-766-6427
• Email: service.us@somnics.com
• Phone: 1-833-766-6427
• Email: service.us@somnics.com
• Phone: 1-833-766-6427
• Email: service.us@somnics.com
• Phone: 1-833-766-6427
• Email: service.us@somnics.com
• Phone: 1-833-766-6427
• Email: service.us@somnics.com
• Phone: 1-833-766-6427
• Email: service.us@somnics.com
• Phone: 1-833-766-6427
• Email: service.us@somnics.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 760 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 760 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 760 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 760 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 760 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 760 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 760 millibar and 1060 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719878320511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193460

FDA Product Code

• OZR: Intraoral Pressure Gradient Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-29
• Device Publish Date: 2021-07-21

On-Brand Devices [iNAP]

• 04719878320115: iNAP Saliva Container
• 04719878320092: iNAP DryPad
• 04719878320078: iNAP Tubing Set
• 04719878320030: iNAP Oral interface
• 04719878320009: iNAP One sleep therapy system whole set package
• 04719878320047: iNAP Oral interface I07S
• 04719878320252: iNAP oral interface - I07H version
• 04719878320184: iNAP One sleep therapy system simple package (console and saliva container)
• 04719878320511: iNAP Muffler
• 04719878320559: A03
• 04719878320061: iNAP Oral Interface
• 04719878320023: iNAP One Sleep Therapy System Console
• 04719878321532: (1) iNAP One Sleep Therapy System [iNAP Console(R07-A) x1, Tubing Set x1, Saliva Container x1, P
• 04719878321525: (1) iNAP One Sleep Therapy System [iNAP Console(R07-A) x1, Tubing Set x1, Saliva Container x1, P
• 04719878320122: iNAP One Sleep Therapy System Console