| Primary Device ID | 00852714003248 |
| NIH Device Record Key | 144af523-0f43-4c60-ae46-9ba663bdfe8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 4TR |
| Version Model Number | AUXP-4TR |
| Company DUNS | 118447207 |
| Company Name | Nuo Therapeutics, Inc. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00852714003248 [Primary] |
| PMQ | Peripheral Blood Processing Device For Wound Management |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-29 |
| Device Publish Date | 2024-03-21 |
| 00852714003248 - 4TR | 2024-03-29Aurix Wound dressing kit single tray with tyvek lidstock label for AGSW-03, 4TR compoonent kit |
| 00852714003248 - 4TR | 2024-03-29 Aurix Wound dressing kit single tray with tyvek lidstock label for AGSW-03, 4TR compoonent kit |
| 00852714003187 - Aurix XL | 2023-04-04 Aurix XL is a phlebotomy convenience kit |
| 00852714003194 - Aurix Multifly 4-Pack | 2023-04-04 4-pack of Safety Needles. |