Duns Number:016898496
Device Description: Bard® Lubricath® Foley Catheter, 30cc Balloon Lubricious Coated
Catalog Number
366724
Brand Name
Bard® Lubricath® Foley Catheter
Version/Model Number
366724
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)
Yes
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
KOD
Product Code Name
CATHETER, UROLOGICAL
Public Device Record Key
9306d0e6-cdef-47de-be9a-ea8f63ad7b12
Public Version Date
December 04, 2020
Public Version Number
8
DI Record Publish Date
July 23, 2016
Package DI Number
10801741077880
Quantity per Package
12
Contains DI Package
00801741077883
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 |