FDA UDI
In Commercial Distribution
🇺🇸 United States
SINUCLEANSE NASAL DRY SALT INHALER
DI: 00646011701002
·
Model: 00-70100
·
Ascent Consumer Products Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SINUCLEANSE NASAL DRY SALT INHALER
- Primary DI
- 00646011701002
- Version / Model
- 00-70100
- Company Name
- Ascent Consumer Products Inc
- Labeler DUNS
- 078396381
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-20
- Public Version
- 1
- Public Version Date
- 2023-12-28
- Public Version Status
- New
- Public Device Record Key
- 8ac4116a-4444-4249-b17e-522510b3713a
Device Description
DRY SALT INHALER
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
- Yes
- 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 |
|---|---|---|---|---|
| KCO | Nasal Spray, Ent Delivery | Ear, Nose, Throat | 874.5220 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38017 | Dry salt inhalation therapy device | A hand-held inhaler prefilled with salt crystals (e.g., natural Miocene halit) and used to provide an inhalation of salt particles through the mouth and into the bronchial airways. Commonly known as a saltpipe, it is a plastic container, containing the salt crystals, with a mouthpiece to enable inhalation. The inhaled sodium (Na) content and salt particles are believed to induce natural self-cleansing mechanisms that flush away the impurities from the surface of cells and mechanically clean the airways. This is a reusable device intended for single-patient use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00646011701002 | GS1 |
Customer Contacts
- Phone
- 1888-547-5492
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 5 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius