FDA UDI
In Commercial Distribution
🇺🇸 United States
Lunoa
DI: 08719689344504
·
Model: L1US01US
·
NightBalance Holding B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Lunoa
- Primary DI
- 08719689344504
- Version / Model
- L1US01US
- Catalog Number
- L1US01US
- Company Name
- NightBalance Holding B.V.
- Labeler DUNS
- 489925212
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-20
- Public Version
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 6d401458-8f52-4cea-8a45-255c8c4c073a
Device Description
Lunoa Sleep Position Trainer, US
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
- 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 |
|---|---|---|---|---|
| MYB | Pillow, cervical (for mild sleep apnea) | Dental | 872.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35503 | Sleep apnoea bed pillow | A specially designed cushion intended to support the head and neck (the cervical region) in a position that is similar to that used in cardiopulmonary resuscitation (CPR), so that the upper airway remains open, thereby reducing the incidence of mild obstructive sleep apnoea. It may also be used to help reduce snoring and improve the quality of sleep. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 08719689344092 | GS1 | ||||
| Primary | 08719689344504 | GS1 |
Customer Contacts
- Phone
- +1(724)387-4000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180608 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius