Duns Number:080935429
Device Description: Urine Leg Bag with Extension Tube
Catalog Number
3433
Brand Name
Dover
Version/Model Number
3433
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2023
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
FAQ
Product Code Name
BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
Public Device Record Key
986274f4-29a7-4b1f-825e-2fe2a60859a9
Public Version Date
November 05, 2021
Public Version Number
6
DI Record Publish Date
June 29, 2018
Package DI Number
10884521003439
Quantity per Package
50
Contains DI Package
20884521003436
Package Discontinue Date
July 01, 2023
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |