| Primary Device ID | 00382830058384 |
| NIH Device Record Key | 36f52b7d-f3fb-449c-9a30-c5944f136aa3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ErgoJust LTM & ICU |
| Version Model Number | IP-HD-EC-VIDEO-EXT |
| Company DUNS | 245258280 |
| Company Name | XLTEK |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382830058384 [Primary] |
| GDC | Table, Operating-Room, Electrical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-20 |
| Device Publish Date | 2023-11-10 |
| 00382830063319 | ErgoJust Desktop Cart |
| 00382830058384 | IP PTZ HD ErgoJust Video Extension |
| 00382830058377 | IP PTZ ErgoJust Video Extension |
| 00382830058360 | ErgoJust ICU Cart Export For Fixed Zoom Video Ext |
| 00382830058353 | ErgoJust ICU Cart Export For PTZ Video Ext |
| 00382830058346 | ErgoJust ICU Cart For Fixed-Zoom Video Ext |
| 00382830058339 | ErgoJust Desktop Cart - 220V |