Duns Number:001292192
Device Description: BD Vacutainer® K2 EDTA 10.8mg
Catalog Number
368661
Brand Name
BD Vacutainer® K2 EDTA 10.8mg
Version/Model Number
368661
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK050036,BK050036
Product Code
JKA
Product Code Name
Tubes, vials, systems, serum separators, blood collection
Public Device Record Key
b3aaf9bc-4c11-4210-be0a-6fe2b0f7041c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 13, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |