| Primary Device ID | 10016169541046 |
| NIH Device Record Key | 554b128b-75d6-4a8b-bead-78cb0e54374c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kimono Swirl |
| Version Model Number | Swirl Silcone Lubricant |
| Catalog Number | 54104 |
| Company DUNS | 175425982 |
| Company Name | MAYER LABORATORIES, INC. |
| 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 | false |
| 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(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com | |
| Phone | +1(510)229-5300 |
| davidm@mayerlabs.com |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00016169541049 [Primary] |
| GS1 | 10016169541046 [Package] Contains: 20016169541043 Package: MASTER CARTON [6 Units] In Commercial Distribution |
| GS1 | 20016169541043 [Package] Contains: 00016169541049 Package: FOLDED CARTON [6 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 | 2023-11-13 |
| Device Publish Date | 2023-11-03 |
| 20016169541050 | Personal Lubricant - Silicone 2 ml |
| 10016169541046 | Personal Lubricant - Silicone 100 ml |
| 10016169540056 | Natural Personal Lubricant 3 ml |
| 20016169540046 | Natural Personal Lubricant - 100 ml |
| 10016169038362 | Latex Condom 36-ct |
| 20016169038123 | Latex Condom 12-ct |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() KIMONO SWIRL 97296474 not registered Live/Pending |
Mayer Laboratories, Inc. 2022-03-04 |