AccessGUDID - DEVICE: Aurora Software Version 1.3 Upgrade Kit (04086000101059)

GUDID

Device Identifier (DI) Information

Brand Name: Aurora Software Version 1.3 Upgrade Kit
Version or Model: 6R2013
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6R2013
Company Name: Fresenius Kabi AG

Primary DI Number: 04086000101059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: A software upgrade package (accessory) to the Aurora Plasmapheresis System (primary device). For collection of plasma by membrane filtration.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16405	Apheresis system	An assembly of electrically-powered devices designed for the extracorporeal separation and removal of a constituent of whole blood (e.g., plasma, platelets, leukocytes) and pathogens, and the return of the remaining constituents to the patient. It typically includes pumps to circulate the blood and uses methods such as membrane filtration, centrifugation, adsorption, or a combination of these to separate the constituent from the blood. The system may be used therapeutically (e.g., to remove immune complexes or low density lipoproteins) or for the harvesting of blood constituents (e.g., for HLA-matched platelets or fresh frozen plasma).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKT	Separator, Automated, Blood Cell, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK160012	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0906c405-f689-4018-8b4b-80a31cb53a3f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016