Para-Pak CON-Trate

Basic Information

• Brand Name: Para-Pak CON-Trate
• Primary DI: 00840733103445
• Version / Model: 960050, 960200 Inner Box
• Catalog Number: 960050, 960200
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Labeler DUNS: 092815364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-27
• Public Version: 1
• Public Version Date: 2021-11-04
• Public Version Status: New
• Public Device Record Key: 815b53da-3bea-429e-b7c8-3ba60a279753

Device Description

The Meridian CON-Trate System is a complete system for concentrating and recovering helminth eggs, larvae and protozoan cysts from feces.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKS	Device, Parasite Concentration	Microbiology	866.2900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63816	Faecal parasite isolation kit IVD	A collection of reagents and other associated materials (e.g., filters, containers) intended to be used for the isolation and concentration of intestinal parasites [e.g., helminth eggs and larvae, protozoan trophozoites and cysts] from a faecal specimen, using one or a combination of techniques (e.g., centrifugation, filtration, organic solvent or surfactant treatment), for further in vitro diagnostic investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840733103445	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius