FDA UDI
In Commercial Distribution
🇺🇸 United States
iNAP
DI: 04719878320023
·
Model: R07-B
·
SOMNICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iNAP
- Primary DI
- 04719878320023
- Version / Model
- R07-B
- Catalog Number
- 11000-07
- Company Name
- SOMNICS, INC.
- Labeler DUNS
- 657169335
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-01
- Public Version
- 1
- Public Version Date
- 2022-06-09
- Public Version Status
- New
- Public Device Record Key
- 6a147689-01dc-42d9-b561-8b5a4bf4c7e9
Device Description
iNAP One Sleep Therapy System Console
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
- 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
- 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 | 04719878320023 | GS1 |
Customer Contacts
- Phone
- 1-833-766-6427
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193460 | 000 |