Duns Number:016898496
Device Description: Extension Tubing, For use with Male External Catheters
Catalog Number
650615
Brand Name
Extension Tubing
Version/Model Number
650615
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
-
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
NNW
Product Code Name
BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE
Public Device Record Key
3c28c6fc-05f9-4eee-af2c-d84817b4256a
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 23, 2020
Package DI Number
10801741050975
Quantity per Package
24
Contains DI Package
00801741050978
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 |