Duns Number:303639066
Device Description: VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, non-ri VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, non-ridged, High Altitude, USA
Catalog Number
454067PH
Brand Name
Vacuette
Version/Model Number
454067PH
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
BK040066,BK050028,K960858,K983952,BK040066,BK050028,K960858,K983952,BK040066,BK050028,K960858,K983952
Product Code
JKA
Product Code Name
Tubes, vials, systems, serum separators, blood collection
Public Device Record Key
7f526cf3-2299-44b0-b9b9-565b275dd009
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
39120049204480
Quantity per Package
24
Contains DI Package
29120049204483
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 |