Duns Number:001292192
Device Description: BD Vacutainer® Specimen Collection Assembly with BD™ Blunt Plastic Cannula
Catalog Number
303380
Brand Name
BD Vacutainer® Specimen Collection with BD™ Blunt Plastic Cannula
Version/Model Number
303380
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
K974363,K974363
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
e6014c53-f262-4be4-8c30-070ad5cd1f2b
Public Version Date
October 23, 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 |