Duns Number:080593067
Device Description: URINARY DRAINAGE LUXURY BAG Contents: One each 2000mL drainage bag equipped with Anti-refl URINARY DRAINAGE LUXURY BAG Contents: One each 2000mL drainage bag equipped with Anti-reflux chamber, universal double hook, bed sheet clamp, T-tap drain port.
Catalog Number
M507
Brand Name
MEDADV
Version/Model Number
M507
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
FON
Product Code Name
Bag, Drainage, With Adhesive, Ostomy
Public Device Record Key
38cbdee2-8d47-400d-8a10-9e38f3a17de1
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
April 11, 2018
Package DI Number
10819667020989
Quantity per Package
40
Contains DI Package
00819667020982
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 40 |