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 |