TriNEST

Basic Information

• Brand Name: TriNEST
• Primary DI: 06438147297726
• Version / Model: 1296-0050
• Catalog Number: 1296-0050
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-25
• Public Version: 3
• Public Version Date: 2023-06-14
• Public Version Status: Update
• Public Device Record Key: 58132064-0ca0-4cbf-878a-db0026c1c974

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JRQ	Shaker/Stirrer	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147297726	GS1