AccessGUDID - DEVICE: Xpeedy (00860012318230)

GUDID

Device Identifier (DI) Information

Brand Name: Xpeedy
Version or Model: DOA20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Cura Diagnostics Inc.

Primary DI Number: 00860012318230
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119132639 *Terms of Use

Device Description: The Xpeedy DOA20 Automated Sample Preparation for Triple Quadrupole LC/MS/MS Analysis is used for fluid pre-treatment and processing of samples in a toxicology lab setting, serving the purpose of sample dilution, subpackaging, incubation and sample transferring.

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?
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
JJH	Clinical Sample Concentrator

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: 5c3eee28-f5f3-4ec3-a965-a40a9e469e37
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 19, 2024