FDA UDI
Not in Commercial Distribution
🇺🇸 United States
3M™ ESPE™
DI: 30348878600016
·
Model: 12136
·
3M COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
9
Basic Information
- Brand Name
- 3M™ ESPE™
- Primary DI
- 30348878600016
- Version / Model
- 12136
- Catalog Number
- 12136
- Company Name
- 3M COMPANY
- Labeler DUNS
- 830016148
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 9
- Record Status
- Published
- Publish Date
- 2018-10-31
- Public Version
- 3
- Public Version Date
- 2023-01-17
- Public Version Status
- Update
- Public Device Record Key
- b5ad6f31-4643-4d18-998f-e43a09b3e0e8
- Distribution End Date
- 2023-01-16
Device Description
3M™ ESPE™ Xerostomia Relief Spray, Sample Pack, 9 Canisters, 12136
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
- 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 |
|---|---|---|---|---|
| 47276 | Oropharyngeal mucosa protection material | A substance intended to be applied to the mouth and/or pharynx to barrier/protect the mucosa from harmful influences (e.g., environmental, infectious), to treat minor pain and irritation, and/or to relieve mucosal dryness (xerostomia). It is comprised of various compounds [e.g., plant extracts, fat-soluble vitamins, hyaluronic acid (HA), glycerol/xylitol, mineral salts, viscosity enhancers, enzymes, and/or syrups]; it does not include a pharmaceutical agent. It is available in various forms (e.g., gel, toothpaste, fluid, tablet, lozenge, spray) typically for use in the home. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50348878600010 | GS1 | CASE | 12 | Not in Commercial Distribution | 2023-01-16 |
| Primary | 30348878600016 | GS1 | ||||
| Unit of Use | 00348878600015 | GS1 |
Customer Contacts
- Phone
- +1(800)634-2249
- [email protected]