| Primary Device ID | 00852714003118 |
| NIH Device Record Key | 6b39e1ed-e123-419a-915e-ede8c40fffc4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aurix Reagent Kit |
| Version Model Number | AGSR-03 |
| Company DUNS | 132418851 |
| 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 | true |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852714003118 [Primary] |
| PMQ | Peripheral Blood Processing Device For Wound Management |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-30 |
| 10852714003108 - Aurix Wound Dressing Kit | 2021-11-01 Aurix Wound Dressing Kit Case of 10 Kits or 10 Trays with 010374 Case Label for AGSW-02 |
| 10852714003122 - Aurix Single Pack Kit | 2021-11-01 Aurix Single Pack Kit Single Kit with 010405 Aurix Single Pack Kit Label |
| 10852714003139 - Aurix Five Pack Kit | 2021-11-01 Aurix Five Pack Kit Case of 5 Wound Dressing Kits and 5 Reagent Kits with 010503 Aurix Five Pack Kit Label |
| 10852714003146 - Aurix Eight Pack Kit | 2021-11-01 Aurix Eight Pack Kit Case of 8 Wound Dressing Kits and 8 Reagent Kits with 010512 Aurix Eight Pack Kit Label |
| 10852714003153 - Aurix Ten Pack Kit | 2021-11-01 Aurix Ten Pack Kit Case of 10 Wound Dressing Kits and 10 Reagent Kits with 010513 Aurix Ten Pack Kit Label |
| 10852714003016 - Angel Processing Sets (NA) | 2021-01-08 Angel Processing Sets (NA) Case of 8 Kits or 8 Trays with 020201 Case Label Processing Set (NA) |
| 10852714003023 - Angel Processing Sets (EU) | 2021-01-08 Angel Processing Sets (EU) Case of 8 Kits or 8 Trays with 016342 Case Label EU Processing Set |
| 00852714003002 - ActivAT | 2018-03-29 ActivAT Single Unit (Kit or Tray) with 966155001 ActivAT Tray Label |