Duns Number:303639066
Device Description: VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 gold cap-white ring, non-ridged, US VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 gold cap-white ring, non-ridged, USA
Catalog Number
454446P
Brand Name
Vacuette
Version/Model Number
454446P
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
K960857,K960857,K960857
Product Code
JKA
Product Code Name
Tubes, vials, systems, serum separators, blood collection
Public Device Record Key
7d678f73-f792-4073-80cf-7ee0e4bc2268
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
39120049204527
Quantity per Package
24
Contains DI Package
29120049204520
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 |