| Primary Device ID | 20860936000369 |
| NIH Device Record Key | db6dfffa-8e72-442b-861b-6cc4c31034f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Urology Set |
| Version Model Number | LL0006 |
| Catalog Number | LL0006 |
| Company DUNS | 022465035 |
| Company Name | THERMEDX, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1.888.542.9277 |
| aturner@thermedx.com |
| Pressure | 400 millibar |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860936000365 [Primary] |
| GS1 | 20860936000369 [Package] Contains: 00860936000365 Package: Box [10 Units] In Commercial Distribution |
| HRX | Arthroscope |
| 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 | 2018-02-01 |
| 00860936000310 - Fluid Management System | 2018-07-06 |
| 00860936000327 - Fluid Management System | 2018-07-06 |
| 20860936000338 - Luer Lock Set, Single Lumen | 2018-07-06 |
| 20860936000345 - High Pressure Luer Lock Set, Single Lumen 300mmHg | 2018-07-06 |
| 20860936000352 - Tubing Set - Single Lumen, Inflow with Dual Outflow | 2018-07-06 |
| 20860936000369 - Urology Set | 2018-07-06Urology Set |
| 20860936000369 - Urology Set | 2018-07-06 Urology Set |