FDA UDI
In Commercial Distribution
🇺🇸 United States
Xerostom® Saliva Substitute Gel
DI: 08426181972769
·
Model: Tube 25ml
·
BIO COSMETICS SL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Xerostom® Saliva Substitute Gel
- Primary DI
- 08426181972769
- Version / Model
- Tube 25ml
- Company Name
- BIO COSMETICS SL
- Labeler DUNS
- 513423178
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-01
- Public Version
- 1
- Public Version Date
- 2024-04-09
- Public Version Status
- New
- Public Device Record Key
- 23e244c1-03a3-4146-98ed-4d07bf5afe9f
Device Description
XEROSTOM® has been formulated to the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication. XEROSTOM® may be used to replace normal saliva, when salivary glands are damaged or not functioning. XEROSTOM® relieves the problems of dry mouth
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LFD | Saliva, Artificial | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37576 | Artificial saliva | An electrolyte solution resembling human saliva designed in part to replace the normal ionic and pH balance of the oral cavity. The device is intended as a mouth rinse to moisten, lubricate, and clean the mucosa of the mouth, tongue, and throat. The device is indicated for dryness of the mouth or throat due to temporary or permanent conditions. 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 | 08426181972769 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature. Use within three months after first opening. Use before expiration date.