FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LUWI - Silicone Lubricant - 5mL/ 0.17mL
DI: 00796494005569
·
Model: 75509
·
CC Wellness LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- LUWI - Silicone Lubricant - 5mL/ 0.17mL
- Primary DI
- 00796494005569
- Version / Model
- 75509
- Company Name
- CC Wellness LLC
- Labeler DUNS
- 067692292
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-28
- Public Version
- 2
- Public Version Date
- 2025-07-31
- Public Version Status
- Update
- Public Device Record Key
- 2e28d838-615b-4f3d-a624-2068625e956c
- Distribution End Date
- 2025-07-30
Device Description
Silicone-Based 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 | 10796494005566 | GS1 | 250 | Not in Commercial Distribution | 2025-07-30 | |
| Primary | 00796494005569 | GS1 |