AccessGUDID - DEVICE: Procleix Xpress® System (00866489000005)

GUDID

Device Identifier (DI) Information

Brand Name: Procleix Xpress® System
Version or Model: 30055067
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30055067
Company Name: GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Primary DI Number: 00866489000005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056570085 *Terms of Use

Device Description: The Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.

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?
37926	Electronic pipette	An electronic, hand-held instrument intended to be used to withdraw, transfer, and inject specific volumes of fluid materials typically from one laboratory container to another, during an in vitro diagnostic procedure. It is typically in the form of a single-channel or multichannel liquid handling device used to deliver fluid materials into one receptacle or several receptacles simultaneously. It may be factory pre-set to deliver a specific volume or enable user-specified volumes within a useful range, visible on an electronic display.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMH	Software, Blood Bank, Stand Alone Products

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK140150	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: 1431f99e-a0d3-4456-90c9-ccd27bb10e5e
Public Version Date: November 19, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2016