Duns Number:016898496
Device Description: Bard® Drainage Protector and Catheter Plug
Catalog Number
000076
Brand Name
Bard® Drainage Protector and Catheter Plug
Version/Model Number
000076
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNY
Product Code Name
ACCESSORIES, CATHETER, G-U
Public Device Record Key
1c5feb3a-9d8f-4cba-bf8a-453752cf4dda
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
September 06, 2016
Package DI Number
10801741052528
Quantity per Package
250
Contains DI Package
00801741052521
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 472 |
2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
U | Unclassified | 10 |