Duns Number:303639066
Device Description: VACUETTE® TUBE 8 ml K2E K2EDTA Separator 16x100 white cap-yellow ring, non-ridged, USA
Catalog Number
455021P
Brand Name
Vacuette
Version/Model Number
455021P
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
K012043,K012043,K012043
Product Code
PJE
Product Code Name
Blood/plasma collection device for DNA testing
Public Device Record Key
eb60f134-e3d1-492a-92fa-a303b60674c3
Public Version Date
January 27, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
39120049204558
Quantity per Package
24
Contains DI Package
29120049204551
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |