Duns Number:345881551
Device Description: This single-use device can be used for In Vitro Diagnostic applications, it is suitable fo This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
Catalog Number
-
Brand Name
Vivafree 500
Version/Model Number
VFR01H23
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
JJH
Product Code Name
Clinical Sample Concentrator
Public Device Record Key
fae58c4a-ebbb-4512-988e-fb8483982d24
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
August 17, 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 | 1 |