iNAP 24000-7H
GUDID 04719878320252
iNAP oral interface - I07H version
SOMNICS, INC.
Intraoral negative-pressure sleep apnoea unit| Primary Device ID | 04719878320252 |
| NIH Device Record Key | 7ae8b55c-796c-4995-a1f6-276b88136bed |
| Commercial Distribution Discontinuation | 2021-06-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | iNAP |
| Version Model Number | 24000-7H |
| Catalog Number | 24000-7H |
| 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 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com | |
| Phone | 1-833-766-6427 |
| service.us@somnics.com |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719878320252 [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 | 2021-06-11 |
| Device Publish Date | 2021-06-03 |
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 |
Trademark Results [iNAP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INAP 90274735 not registered Live/Pending |
Somnics Inc. 2020-10-23 |
 INAP 88782903 not registered Live/Pending |
Internap Corporation 2020-02-03 |
 INAP 87198416 5413818 Live/Registered |
Internap Corporation 2016-10-10 |
 INAP 87178732 5413797 Live/Registered |
Internap Corporation 2016-09-21 |
 INAP 85646633 4518385 Live/Registered |
SOMNICS, INC. 2012-06-08 |
 INAP 77798238 not registered Dead/Abandoned |
JELLE PRINS 2009-08-06 |
 INAP 77647813 not registered Dead/Abandoned |
Net-A-Porter Limited 2009-01-12 |
 INAP 75632879 not registered Dead/Abandoned |
Cabral, Rene Alexander 1999-02-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.