| Primary Device ID | 18800105200157 |
| NIH Device Record Key | 43d209e8-ca39-46a6-95a9-9eec1d90dae9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WROOTBOL NOTIPATCH |
| Version Model Number | DR-TZ+365 |
| Company DUNS | 694627986 |
| Company Name | ONE POWER |
| 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 | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800105200150 [Primary] |
| GS1 | 18800105200157 [Package] Contains: 08800105200150 Package: Cardboard Box [800 Units] In Commercial Distribution |
| FQZ | Thermometer, Clinical Color Change |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-25 |
| Device Publish Date | 2021-05-17 |
| 18800105200157 - WROOTBOL NOTIPATCH | 2021-05-25Thermometer, colour-indicating |
| 18800105200157 - WROOTBOL NOTIPATCH | 2021-05-25 Thermometer, colour-indicating |
| 08800105200020 - Dr.Tempzone+ | 2020-12-15 Thermometer, colour-indicating |
| 08800105200037 - Dr.Tempzone+ | 2020-12-15 Thermometer, colour-indicating |
| 18800105200027 - Dr.Tempzone+ | 2020-11-10 Thermometer, colour-indicating |
| 18800105200034 - Dr.Tempzone+ | 2020-11-10 Thermometer, colour-indicating |