Duns Number:080580521
Catalog Number
-
Brand Name
Bashir™ Endovascular Catheter
Version/Model Number
7201
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"
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
K183290,K183290
Product Code
KRA
Product Code Name
Catheter, Continuous Flush
Public Device Record Key
1819cd34-31a3-48e4-90ff-5f802c8bc179
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
April 10, 2019
Package DI Number
10850005115004
Quantity per Package
16
Contains DI Package
00850005115007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |