FDA UDI
In Commercial Distribution
🇺🇸 United States
Naväge Baby
DI: 00850027492889
·
Model: BMM-1
·
Rhinosystems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Naväge Baby
- Primary DI
- 00850027492889
- Version / Model
- BMM-1
- Company Name
- Rhinosystems, Inc.
- Labeler DUNS
- 008016231
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-29
- Public Version
- 1
- Public Version Date
- 2025-11-06
- Public Version Status
- New
- Public Device Record Key
- 7f4ae347-2d9f-490d-ac78-a498a06e5c4e
Device Description
Micro-Mist Inhaler 2-Pack with 1 mask
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCO | Nasal Spray, Ent Delivery | Ear, Nose, Throat | 874.5220 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56700 | Nasal irrigation saline solution | A water-based, salt solution (e.g., isotonic or hypertonic mineral-rich purified sea water) intended to penetrate, clear, clean, and sometimes hydrate the nasal passages and sinus cavity. The solution is typically self-administered (e.g., via a squeeze bottle, glass bottle with a mechanical spray pump, dropper or aerosol) for preventive or symptomatic nasal care. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850027492889 | GS1 |
Customer Contacts
- Phone
- 1-800-203-6400
- [email protected]