Para-Pak SAF / Clean / C&S - Para-Pak systems are systems for the routine - MERIDIAN BIOSCIENCE, INC.

Duns Number:092815364

Device Description: Para-Pak systems are systems for the routine collection, transportation, preservation, and Para-Pak systems are systems for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.

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More Product Details

Catalog Number

330384

Brand Name

Para-Pak SAF / Clean / C&S

Version/Model Number

330384

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMH

Product Code Name

Container, Specimen, Sterile

Device Record Status

Public Device Record Key

27d77619-e726-4741-8c91-1eaf52ab0ecb

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 10, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERIDIAN BIOSCIENCE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 149
2 A medical device with a moderate to high risk that requires special controls. 46
3 A medical device with high risk that requires premarket approval 1