Kimono Swirl 3836
GUDID 10016169038362
Latex Condom 36-ct
MAYER LABORATORIES, INC.
Basic male condom, Hevea-latex| Primary Device ID | 10016169038362 |
| NIH Device Record Key | 8235c20a-1cf8-4a53-9a1a-43e93e604f5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kimono Swirl |
| Version Model Number | Swirl Latex Condoms |
| Catalog Number | 3836 |
| Company DUNS | 175425982 |
| Company Name | MAYER LABORATORIES, INC. |
| Device Count | 36 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| 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 |
Device Dimensions
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
| Width | 54 Millimeter |
| Length | 160 Millimeter |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00016169038365 [Primary] |
| GS1 | 10016169038362 [Package] Contains: 20016169038369 Package: MASTER CARTON [8 Units] In Commercial Distribution |
| GS1 | 20016169038369 [Package] Contains: 00016169038365 Package: FOLDED CARTON [6 Units] In Commercial Distribution |
| GS1 | 30016169038366 [Unit of Use] |
FDA Product Code
| HIS | CONDOM |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-13 |
| Device Publish Date | 2023-11-03 |
On-Brand Devices [Kimono Swirl]
| 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 |
Trademark Results [Kimono Swirl]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KIMONO SWIRL 97296474 not registered Live/Pending |
Mayer Laboratories, Inc. 2022-03-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.