Duns Number:124987988
Device Description: US CATHENA 20GX1.00IN WINGED BC
Catalog Number
386883
Brand Name
BD Cathena™ Safety IV Catheter
Version/Model Number
386883
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
d07d1f6b-3726-4431-b5aa-372c5c033ccc
Public Version Date
November 15, 2021
Public Version Number
2
DI Record Publish Date
November 02, 2020
Package DI Number
30382903868835
Quantity per Package
30
Contains DI Package
00382903868834
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 |