| Primary Device ID | B040XE21262U |
| NIH Device Record Key | f9fa7daf-4849-497a-bcdc-75ad2f1d4682 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Myocardial Needle Temperature Probe |
| Version Model Number | XE2126 |
| Company DUNS | 939872651 |
| Company Name | GENESEE BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B040XE21261 [Primary] |
| HIBCC | B040XE21262U [Package] Contains: B040XE21261 Package: [1 Units] In Commercial Distribution |
| FLL | Thermometer, Electronic, Clinical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-01 |
| B040XE24252W | Myocardial Needle Temperature Probe |
| B040XE21262U | Myocardial Needle Temperature Probe |
| B040XE21252T | Myocardial Needle Temperature Probe |
| B04024262T | Myocardial Needle Temperature Probe |
| B04024242R | Myocardial Needle Temperature Probe |
| B04024232Q | Myocardial Needle Temperature Probe |
| B04021242O | Myocardial Needle Temperature Probe |
| B04021232N | Myocardial Needle Temperature Probe |