Duns Number:221434843
Device Description: TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood specimens for immunophenotyping of white blood cells by flow cytometry. Recovery of lymphocyte subset markers of the HIV panel can be accomplished over a 14-day period following collection. TVTs are in-vitro diagnostic medical devices.
Catalog Number
-
Brand Name
TransFix/EDTA Vacuum Blood Collection Tubes
Version/Model Number
TVT-03-50-US
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
K162723,K162723,K162723,K162723
Product Code
GIM
Product Code Name
Tubes, Vacuum Sample, With Anticoagulant
Public Device Record Key
814fb25f-2e12-4cf5-be67-97f5861e0424
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 02, 2018
Package DI Number
35060531711628
Quantity per Package
2
Contains DI Package
05060531711627
Package Discontinue Date
-
Package Status
-
Package Type
Pouch