iNAP One 91010-9H

GUDID 04719878320535

R07-B, C07, T01, I07H, A03*3, P01

SOMNICS, INC.

Intraoral negative-pressure sleep apnoea unit Intraoral negative-pressure sleep apnoea unit Intraoral negative-pressure sleep apnoea unit Intraoral negative-pressure sleep apnoea unit Intraoral negative-pressure sleep apnoea unit Intraoral negative-pressure sleep apnoea unit Intraoral negative-pressure sleep apnoea unit

• Primary Device ID: 04719878320535
• NIH Device Record Key: 84aa7c8f-c3a6-4ec5-a210-b95867dfb73e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iNAP One
• Version Model Number: Quarterly Set w/I07H
• Catalog Number: 91010-9H
• Company DUNS: 657169335
• Company Name: SOMNICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719878320535 [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: 2022-06-23
• Device Publish Date: 2022-06-15

On-Brand Devices [iNAP One ]

• 04719878320887: iNAP One Quarterly Kit
• 04719878320542: R07-B, C07, T01, I07S, A03*3, P01
• 04719878320535: R07-B, C07, T01, I07H, A03*3, P01
• 04719878320528: R07-B, C07, T01, I07, A03*3, P01
• 04719878320108: Power Adapter
• 04719878321075: iNAP One Quarterly Kit (with I07)
• 04719878321105: R07-B, C07, T01, I07H, A03*3, P01, ZeeBud
• 04719878321099: R07-B, C07, T01, I07, A03*3, P01, ZeeBud