AccessGUDID - DEVICE: Freedom EVO® (07640137480127)

GUDID

Device Identifier (DI) Information

Brand Name: Freedom EVO®
Version or Model: FREEDOM EVO-2 100 BASE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30020010
Company Name: Tecan Schweiz AG

Primary DI Number: 07640137480127
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481151509 *Terms of Use

Device Description: configurable liquid handling workstation

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
OTV	Research Use Only/Clinical Chemistry Devices

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: 69a04c2a-54c0-43a0-9d88-a9da627ef044
Public Version Date: December 30, 2021
Public Version Number: 1
DI Record Publish Date: December 22, 2021