FDA UDI
In Commercial Distribution
🇺🇸 United States
CVS Dry Mouth Spray
DI: D132DMS0010
·
Model: 001
·
Oralabs, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CVS Dry Mouth Spray
- Primary DI
- D132DMS0010
- Version / Model
- 001
- Company Name
- Oralabs, LLC
- Labeler DUNS
- 801824756
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-14
- Public Version
- 1
- Public Version Date
- 2023-08-22
- Public Version Status
- New
- Public Device Record Key
- 6a43cdba-2b1c-4df7-8cb9-ff474375a215
Device Description
Artificial Saliva - Dry Mouth Spray
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 | D132DMS0010 | HIBCC | ||||
| Secondary | 00050428277362 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181839 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 7.5 | Milliliter |