Duns Number:488489766
Device Description: The collecting bag is non-patient contacting and is attached to the silicon outflow tube o The collecting bag is non-patient contacting and is attached to the silicon outflow tube on the proximal end of the catheter. The fluid aspirated by the catheter passes through the catheters’ outflow tubing into the Collecting bag.
Catalog Number
10170
Brand Name
Collecting Bag 2000ml (Straub Medical®)
Version/Model Number
Version 1.0
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)
Yes
Over the Counter (OTC)
-
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
3a30fe23-eb0a-45a3-82d8-6ec76fe85264
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
January 31, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 34 |