AccessGUDID - DEVICE: TriNEST (06438147297726)

GUDID

Device Identifier (DI) Information

Brand Name: TriNEST
Version or Model: 1296-0050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1296-0050
Company Name: Wallac Oy

Primary DI Number: 06438147297726
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

Device Description: The TriNEST™ microplate incubator and shaker is intended for use in laboratories where incubation and shaking of microplates is needed.

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:	Yes
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?
65432	Laboratory shaker IVD	An electromechanical in vitro diagnostic device designed to shake/stir samples or mixtures with a rapid and forceful movement. It is used to provide a rapid mixing or to prevent substances comprised of different components from separation or sedimentation because of their different densities. It may be designed to secure single and/or multiple specimen containers (e.g., test tube, microplate) or specimen container holders during the shaking cycle; some types may have selectable agitation frequencies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JRQ	Shaker/Stirrer

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: 58132064-0ca0-4cbf-878a-db0026c1c974
Public Version Date: June 14, 2023
Public Version Number: 3
DI Record Publish Date: February 25, 2019