Para-Pak ULTRA 10% Formalin

Basic Information

• Brand Name: Para-Pak ULTRA 10% Formalin
• Primary DI: 00840733103377
• Version / Model: 9004-03
• Catalog Number: 980412
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Labeler DUNS: 092815364
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-14
• Public Version: 2
• Public Version Date: 2023-11-23
• Public Version Status: Update
• Public Device Record Key: 68d2ecc0-366a-4303-a4e4-e5b7e0ca32d0
• Distribution End Date: 2023-11-22

Device Description

This form represents the UDI present on the individual vials. Para-Pak Ultra based systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transport.

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
IGG	Formaldehyde (Formalin, Formol)	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57911	Faecal specimen container IVD, transport buffer/medium	A covered receptacle containing transport buffer solution or microbiological medium (e.g., Carey-Blair transport medium) intended to be used for the collection, preservation, and transport of a faecal specimen for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840733103377	GS1

Customer Contacts

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