| Primary Device ID | 00817770020554 |
| NIH Device Record Key | 2947dbab-ab90-454c-950d-ca0b41710601 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PULSOX-300i |
| Version Model Number | R204P18-002 |
| Company DUNS | 169911828 |
| Company Name | MAXTEC, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00817770020554 [Primary] |
| DQA | Oximeter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-14 |
| Device Publish Date | 2016-09-26 |
| 00817770021001 | Oximeter Monitor |
| 00817770020653 | Oximeter with Soft Tip Probe |
| 00817770020646 | Oximeter with Spot Check Probe |
| 00817770020639 | Oximeter with Finger Probe |
| 00817770020578 | Oximeter Sleep Study with Soft Tip Probe and without Software |
| 00817770020554 | Oximeter Sleep Study with Soft Tip Probe |
| 00817770020547 | Oximeter Sleep Study without Software |
| 00817770020530 | Oximeter Sleep Study |