Para-Pak Macro-CON

Basic Information

• Brand Name: Para-Pak Macro-CON
• Primary DI: 00840733102028
• Version / Model: 970120
• Catalog Number: 970120
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Labeler DUNS: 092815364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-26
• Public Version: 1
• Public Version Date: 2020-11-03
• Public Version Status: New
• Public Device Record Key: f258bd59-14cc-4586-816b-d0756c2d8076

Device Description

Para-Pak Macro-CON is a system for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. The filtration unit is designed to be used directly with the Para-Pak specimen collection vial. This creates a completely closed system, minimizing exposure of the user to potentially infectious agents. Macro-CON concentration utilizes the entire contents of the Para-Pak specimen collection vial, reducing variation due to specimen sampling. This is of particular advantage to the clinical parasitologist when a small number of organisms may be present in a large volume of stool.

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	00840733102028	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K860034	000

Storage Conditions

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