AccessGUDID - DEVICE: Aurora Xi Plasmapheresis System (04086000101523)

GUDID

Device Identifier (DI) Information

Brand Name: Aurora Xi Plasmapheresis System
Version or Model: 6R4612
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6R4612
Company Name: Fresenius Kabi AG

Primary DI Number: 04086000101523
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: For collection of plasma by membrane filtration.For Use With the Plasmacell Xi Disposable Sets.

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):	Yes
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 [?]
BK160028	0
BK170057	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
Special Storage Condition, Specify: Altitude 0 – 15000 feet
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7a4ce3bf-522a-4599-8d96-0129558b469b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 02, 2017