Duns Number:092815364
Device Description: The Para-Pak system is a convenient system for the routine collection, transportation, pre The Para-Pak system is a convenient system for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites / bacterial pathogens. It is designed for easy collection of specimens by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
Catalog Number
331312
Brand Name
Para-Pak EcoFix / C&S / Clean
Version/Model Number
331312
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMH
Product Code Name
Container, Specimen, Sterile
Public Device Record Key
a77a91f9-392a-4a70-9bbc-27e54af2e937
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
December 10, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |