FDA UDI
Not in Commercial Distribution
🇺🇸 United States
KY Warming Jelly Lubricant
DI: 88067981089484
·
Model: Personal Lubricant
·
RB Health (us) LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- KY Warming Jelly Lubricant
- Primary DI
- 88067981089484
- Version / Model
- Personal Lubricant
- Company Name
- RB Health (us) LLC
- Labeler DUNS
- 081049410
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 6
- Public Version Date
- 2023-12-07
- Public Version Status
- Update
- Public Device Record Key
- 6af8e005-a0c1-46f1-9b51-48cc6d356503
- Distribution End Date
- 2023-12-05
Device Description
Personal Lubricant
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 34131 | Vaginal lubricant | A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. 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 | 77067981089488 | GS1 | Tube | 6 | Not in Commercial Distribution | 2023-12-05 |
| Primary | 88067981089484 | GS1 | ||||
| Package | 20067981089480 | GS1 | Case | 4 | Not in Commercial Distribution | 2023-12-05 |
Customer Contacts
- Phone
- +1(800)756-5488
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040164 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place away from direct sunlight