Duns Number:092815364
Device Description: Para-Pak Ultra EcoFix is a convenient one vial system for the routine collection, transpor Para-Pak Ultra 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 EcoFix preserved specimen. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport.
Catalog Number
9014-03
Brand Name
Para-Pak Ultra EcoFix
Version/Model Number
9014-03
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
49aa530e-7854-4413-bfbf-5d1f4d3f483b
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
July 06, 2021
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 |