FDA UDI
In Commercial Distribution
🇺🇸 United States
Lush
DI: 00864785000231
·
Model: Lush 17 fl oz Silicone Lubricant
·
WESTRIDGE LABORATORIES INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Lush
- Primary DI
- 00864785000231
- Version / Model
- Lush 17 fl oz Silicone Lubricant
- Company Name
- WESTRIDGE LABORATORIES INCORPORATED
- Labeler DUNS
- 879057065
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-21
- Public Version
- 5
- Public Version Date
- 2020-08-07
- Public Version Status
- Update
- Public Device Record Key
- 3ce3eba0-3d24-4273-a6ef-99b72c25a005
Device Description
A silicone lubricant that is latex compatible.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 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 | 30864785000232 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00864785000231 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141767 | 000 |