| Primary Device ID | G137DE100TS0 |
| NIH Device Record Key | 8ead1650-b8ec-4a2e-8b4e-a5938a6d279f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DryEasy |
| Version Model Number | DE100TS |
| Company DUNS | 663330147 |
| Company Name | Marvelworks Limited |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G137DE100TS0 [Primary] |
| KPN | Alarm, Conditioned Response Enuresis |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-02-28 |
| Device Publish Date | 2021-09-06 |
| G137DE100TS0 | DryEasy Bedwetting Alarm |
| G137DE3000 | DryEasy Plus Wireless Bedwetting Alarm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DRYEASY 87883332 not registered Live/Pending |
MARVELWORKS LIMITED 2018-04-19 |