AccessGUDID - DEVICE: Parsortix® PC1 system (05056364200087)

GUDID

Device Identifier (DI) Information

Brand Name: Parsortix® PC1 system
Version or Model: PTX-PCI-IVD-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ANGLE PLC

Primary DI Number: 05056364200087
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 737269212 *Terms of Use

Device Description: Parsortix PC1 instrument pre-loaded with the application software and provided with accessories.

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?
66860	Circulating tumour cell separation system channelling instrument IVD	An electrically-powered, semi-automated laboratory instrument intended to be used for the separation and collection of circulating tumour cells of a specified size and/or deformity from a whole blood specimen using a mechanical separation method (e.g., microfluidics). It is a software-operated instrument with pneumatic and hydraulic components (e.g., reservoir bottles, tubes) which channels the blood specimen through a microfluidic cassette (not included), where the circulating tumour cells are concentrated and contained for subsequent in vitro diagnostic analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QSA	Circulating Tumor Cell (Ctc) Enrichment Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN200062	000

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: 3606d62c-9551-4fa2-a8c7-301810f84895
Public Version Date: April 09, 2024
Public Version Number: 1
DI Record Publish Date: April 01, 2024