Para-Pak CLEAN

Basic Information

• Brand Name: Para-Pak CLEAN
• Primary DI: 00840733101892
• Version / Model: 900312
• Catalog Number: 900312
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Labeler DUNS: 092815364
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-09
• Public Version: 2
• Public Version Date: 2021-06-21
• Public Version Status: Update
• Public Device Record Key: 24626990-ac3d-4097-b6ce-1fbf1d1b1cf2
• Distribution End Date: 2021-05-19

Device Description

Device for the collection, transportation, preservation and examination of stool specimens containing intestinal parasites.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
FMH	Container, Specimen, Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57907	Faecal specimen container IVD, no additive	A covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a faecal specimen for culture, analysis, and/or other 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	00840733101892	GS1

Customer Contacts

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