| Primary Device ID | 00382830061889 |
| NIH Device Record Key | 04748a5d-7915-4be6-99b2-457ff17920f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALGO Pro |
| Version Model Number | 036177 |
| Company DUNS | 245258280 |
| Company Name | XLTEK |
| 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382830061889 [Primary] |
| GWJ | Stimulator, Auditory, Evoked Response |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-05 |
| Device Publish Date | 2024-03-28 |
| 00382830062497 | ALGO Pro Mobile cart |
| 00382830062428 | ALGO Pro Bassinet Hook |
| 00382830062411 | ALGO Pro DC-DC convertor |
| 00382830062039 | ALGO Pro PCA cable 36 inch |
| 00382830062022 | ALGO Pro PCA cable 36 inch |
| 00382830062015 | AALGO Pro ATA cable 72 inch |
| 00382830062008 | ALGO Pro ATA cable 36 inch |
| 00382830061896 | ALGO Pro Docking Station |
| 00382830061889 | ALGO Pro Newborn Hearing Screening Device |