Duns Number:305524696
Device Description: Conveen Security+. Urine collection bag.Leg bag. Inlet tube: 20 inch (50 cm). Clamp outlet Conveen Security+. Urine collection bag.Leg bag. Inlet tube: 20 inch (50 cm). Clamp outlet. incl. 10 x strap set (non-sterile). Volume 17 oz (500 ml).
Catalog Number
21026
Brand Name
Conveen Security+
Version/Model Number
21026
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)
-
Over the Counter (OTC)
Yes
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
4fd83ce0-6fe4-493f-9e1e-1be3a9971563
Public Version Date
March 21, 2022
Public Version Number
1
DI Record Publish Date
March 11, 2022
Package DI Number
05708932539258
Quantity per Package
6
Contains DI Package
05708932539241
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |