FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Well at Walgreens
DI: 00311917189604
·
Model: 189604
·
WALGREEN CO.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- Well at Walgreens
- Primary DI
- 00311917189604
- Version / Model
- 189604
- Catalog Number
- 973212
- Company Name
- WALGREEN CO.
- Labeler DUNS
- 008965063
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-11-16
- Public Version
- 5
- Public Version Date
- 2020-08-07
- Public Version Status
- Update
- Public Device Record Key
- 900f3fa7-b9b9-4742-87ac-2d11caa2727f
- Distribution End Date
- 2016-11-21
Device Description
Well at Walgreens Couples Lubricant
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
- 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 |
|---|---|---|---|---|
| NUC | Lubricant, Personal | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60412 | Sexual lubricant | A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. 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 | 1031191718961 | GS1 | Case | 24 | Not in Commercial Distribution | 2016-11-21 |
| Primary | 00311917189604 | GS1 | ||||
| Unit of Use | 20311917189608 | GS1 |
Customer Contacts
- Phone
- 1-800-351-0177
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060145 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.25 | Pound |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 48 – 87 Degrees Fahrenheit