| Primary Device ID | 00853061006968 |
| NIH Device Record Key | c49511d2-cd28-43e6-a5b0-4807fd006222 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAXO2ME |
| Version Model Number | R230P01-002 |
| 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 | true |
| 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 | 00853061006968 [Primary] |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-27 |
| 10817770021121 - SmartStack | 2023-10-18 IV Pole 8 Pack |
| 00817770020561 - EyeMax2 | 2023-06-20 EyeMax2 Kit (Contains a 20/pack each of Regular, Preemie, and Micro) |
| 00817770020974 - Flowmeter | 2023-06-20 0-70 LMP Oxygen Flowmeter NPT Female Fitting 60 PSI White Knob |
| 00817770025818 - EyeMax2 | 2023-06-20 EyeMax2 Micro 20/Pack Italian (Italian Label) |
| 00817770025825 - EyeMax2 | 2023-06-20 EyeMax2 Preemie Italian 20/Pack (Italian Label) |
| 00817770025832 - EyeMax2 | 2023-06-20 EyeMax2 Regular 20/Pack (Italian Label) |
| 00817770022213 - SmartStack | 2023-06-16 SmartStack Bundle |
| 00817770022220 - SmartStack | 2023-06-16 SmartStack Bundle with Dual Tank Holder |