FDA UDI
In Commercial Distribution
🇺🇸 United States
KY Warming Jelly
DI: 00067981089486
·
Model: 00067981089486
·
RB Health (us) LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- KY Warming Jelly
- Primary DI
- 00067981089486
- Version / Model
- 00067981089486
- Company Name
- RB Health (us) LLC
- Labeler DUNS
- 081049410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-09
- Public Version
- 1
- Public Version Date
- 2025-12-17
- Public Version Status
- New
- Public Device Record Key
- 37317170-c466-490d-beb2-6c739d91bc9c
Device Description
Lubricant 5oz.
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 |
|---|---|---|---|---|
| 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 | 10067981088042 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00067981089486 | GS1 |
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
- Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight