Duns Number:124987988
Device Description: ANGIOCATH SPECIAL TAN 10GA X 3.0IN
Catalog Number
382287
Brand Name
BD Angiocath
Version/Model Number
382287
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Product Code
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
08faef25-96ec-46d3-add4-0d11fc1915cf
Public Version Date
November 15, 2021
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
50382903822879
Quantity per Package
5
Contains DI Package
30382903822875
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
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 |