| Primary Device ID | 00851962007718 |
| NIH Device Record Key | cdb539eb-0947-4d14-81a4-3253ab3cac15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | P-2040 |
| Version Model Number | P-2040 |
| Company DUNS | 139782767 |
| Company Name | ENTHERMICS, INC. |
| 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 | false |
| Serial Number | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851962007718 [Primary] |
| LHC | Warmer, Irrigation Solution |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-11 |
| Device Publish Date | 2022-07-01 |
| 00851962007695 - EC1540 | 2022-07-11 15.4 cu ft irrigation fluid warmer |
| 00851962007701 - MED3373 | 2022-07-11 15.4 cu ft irrigation fluid warmer |
| 00851962007718 - P-2040 | 2022-07-1115.4 cu ft irrigation fluid warmer |
| 00851962007718 - P-2040 | 2022-07-11 15.4 cu ft irrigation fluid warmer |
| 00851962007572 - MEDIVNOW | 2021-06-04 modular fluid warmer |
| 00851962007619 - MED2422-L | 2021-06-04 2.5 cu ft zone heating fluid warmer |
| 00851962007626 - MED2428-L | 2021-06-04 3.5 cu ft zone heating fluid warmer |
| 00851962007633 - MED2226 | 2021-06-04 30" width single cavity zone heating blanket and fluid warmer, 18" depth |
| 00851962007640 - MED2926 | 2021-06-04 30" width single cavity zone heating blanket and fluid warmer, 24" depth |