Duns Number:092815364
Device Description: The Para-Pak EcoFix is a convenient, one-vial system for the routine collection, transport The Para-Pak EcoFix is a convenient, one-vial system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Both concentration and permanent stain may be performed from the EcoFix preserved specimen. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport.
Catalog Number
991320
Brand Name
Para-Pak EcoFix in Biobags
Version/Model Number
991320
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LDX
Product Code Name
Fixative, Metallic Containing
Public Device Record Key
6b8f6081-9a3a-4656-904f-1e5a4e193290
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
December 09, 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 |