Duns Number:124987988
Device Description: US CATHENA 24GX0.75IN WINGED
Catalog Number
386879
Brand Name
BD Cathena™ Safety IV Catheter
Version/Model Number
386879
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"
Yes
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
c64d7a6d-0ec4-40c3-bd6b-8db0f5ab305b
Public Version Date
November 15, 2021
Public Version Number
2
DI Record Publish Date
January 04, 2021
Package DI Number
30382903868798
Quantity per Package
30
Contains DI Package
00382903868797
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfpack
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 |