| Primary Device ID | 10471765290474 |
| NIH Device Record Key | 0f1ed7e4-1f55-47e4-bbb7-3e994de1f03b |
| Commercial Distribution Discontinuation | 2020-10-19 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Pelimex |
| Version Model Number | ACT2230Express Dual |
| Catalog Number | ACT2230Express Dual |
| Company DUNS | 658097795 |
| Company Name | EASYWELL BIOMEDICALS, INC. |
| Device Count | 100 |
| 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 | true |
| 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 |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00047165290474 [Unit of Use] |
| GS1 | 10471765290474 [Primary] |
| GS1 | 30471765290474 [Package] Package: carton [6 Units] Discontinued: 2020-10-19 Not in Commercial Distribution |
| FLL | Thermometer, Electronic, Clinical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-10-19 |
| Device Publish Date | 2016-10-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PELIMEX 79134368 not registered Dead/Abandoned |
PELIMEX 2013-03-14 |