Duns Number:016898496
Device Description: Bard® Wide Leg Bag Straps
Catalog Number
162310
Brand Name
Bard® Wide Leg Bag Straps
Version/Model Number
162310
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
-
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
KNX
Product Code Name
COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
Public Device Record Key
c8aba8ae-1185-4654-869d-fb82e1fb160b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 06, 2018
Package DI Number
10801741137430
Quantity per Package
12
Contains DI Package
00801741137433
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 |