AccessGUDID - DEVICE: Sample Preparation System PS-10 (04987562501908)

GUDID

Device Identifier (DI) Information

Brand Name: Sample Preparation System PS-10
Version or Model: PS-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYSMEX CORPORATION

Primary DI Number: 04987562501908
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690664461 *Terms of Use

Device Description: The Sample Preparation System PS-10 is a fully automated, user-configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.

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?
65174	Pipetting system IVD	An electrically-powered, software-operated instrument intended to be used in the laboratory to withdraw, transfer, and/or inject volumes of fluid materials, typically from one laboratory container to another, during an in vitro diagnostic procedure. The device is programmable to allow for automated single and/or multichannel fluid handling and delivery of user-specified volumes into a single container or multiple containers (e.g., microplate) simultaneously. It has no other specimen processing capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PER	Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 8df528c8-052f-4a71-818a-f188724f94d3
Public Version Date: December 08, 2022
Public Version Number: 1
DI Record Publish Date: November 30, 2022