Duns Number:303639066
Device Description: VACUETTE® TUBE 2 ml Z No Additive 13x75 black cap-yellow ring, non-ridged, High Altitude
Catalog Number
454318H
Brand Name
Vacuette
Version/Model Number
454318H
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,BK050026,BK040066,BK050026,BK040066,BK050026
Product Code
JKA
Product Code Name
Tubes, vials, systems, serum separators, blood collection
Public Device Record Key
0bde274c-09c2-4938-9540-c2b3f3866644
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
June 01, 2017
Package DI Number
39120049206842
Quantity per Package
24
Contains DI Package
29120049206845
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 |