Duns Number:001292192
Device Description: BD Vacutainer® Buffered Sodium Citrate: 0.5 mL – 0.105M
Catalog Number
368026
Brand Name
BD Vacutainer® Buffered Cit. Na. (9:1) 0.105M = 3.2% 4.5mL
Version/Model Number
368026
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 05, 2018
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
K945952,K945952
Product Code
JKA
Product Code Name
Tubes, vials, systems, serum separators, blood collection
Public Device Record Key
c6f53726-96dd-4382-800b-0a890bc96a89
Public Version Date
May 06, 2019
Public Version Number
4
DI Record Publish Date
October 25, 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 |