Para-Pak Ultra EcoFix / C&S / Clean

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name: Para-Pak Ultra EcoFix / C&S / Clean FDA UDI
Generic Name: Faecal specimen container IVD, transport buffer/medium FDA UDI
Device Name: Para-Pak systems are convenient system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. The systems are designed for easy collection of specimens by individuals not trained in microbiological techniques and affords and excellent means of minimizing the adverse effects of delay in specimen transport. FDA UDI
Model / Reference: 331612 FDA UDI
Description: Para-Pak systems are convenient system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. The systems are designed for easy collection of specimens by individuals not trained in microbiological techniques and affords and excellent means of minimizing the adverse effects of delay in specimen transport. FDA UDI

Identifiers

Catalog Number: 331612 FDA UDI
Primary DI / UDI-DI: 00840733103223 FDA UDI
FDA Product Code: LDX FDA UDI
JSM FDA UDI
FMH FDA UDI
GMDN Term: Faecal specimen container IVD, transport buffer/medium FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4010 FDA UDI
866.2390 FDA UDI
864.3250 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Para-Pak Ultra EcoFix / C&S / Clean by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Meridian Bioscience, Inc.

Sources (1)

FDA UDI 7a8a4932-b6da-4543-95e9-8a6640e57605 37 fields · synced May 31, 2026