Duns Number:002348191
Device Description: RUSCH Large Leg bag with Easy-Tap & PVC Extension Tubing
Catalog Number
453932
Brand Name
RUSCH
Version/Model Number
IPN054586
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
-
Product Code
FAQ
Product Code Name
BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
Public Device Record Key
9ca5c839-ee76-429f-a7f7-7414dda30ff5
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
June 20, 2019
Package DI Number
24026704645750
Quantity per Package
24
Contains DI Package
14026704645753
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |