Primary Device ID | 10852714003146 |
NIH Device Record Key | 2b15f01a-88e1-4c71-b020-2cde1f8afe90 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Aurix Eight Pack Kit |
Version Model Number | AUSP-08 |
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 | 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 | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10852714003146 [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 | 3 |
Public Version Date | 2021-11-01 |
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 | 2021-11-01Aurix Eight Pack Kit Case of 8 Wound Dressing Kits and 8 Reagent Kits with 010512 Aurix Eight 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 |