| Primary Device ID | 10067981088042 |
| NIH Device Record Key | 37317170-c466-490d-beb2-6c739d91bc9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KY Warming Jelly |
| Version Model Number | 00067981089486 |
| Company DUNS | 081049410 |
| Company Name | RB Health (us) LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00067981089486 [Primary] |
| GS1 | 10067981088042 [Package] Contains: 00067981089486 Package: Case [24 Units] In Commercial Distribution |
| NUC | Lubricant, Personal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-17 |
| Device Publish Date | 2025-12-09 |
| 10067981993773 | Lubricant |
| 77067981993778 | Lubricant |
| 10067981088042 | Lubricant 5oz. |
| 10067981088059 | Lubricant 2.5 |