Duns Number:303639066
Device Description: VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 mint green cap-yellow ring, non-rid VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 mint green cap-yellow ring, non-ridged
Catalog Number
454493P
Brand Name
Vacuette
Version/Model Number
454493P
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
3eaac059-27bf-4c1c-b27c-7e284a1c5f37
Public Version Date
March 27, 2020
Public Version Number
1
DI Record Publish Date
March 19, 2020
Package DI Number
39120049208204
Quantity per Package
24
Contains DI Package
29120049208207
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 |