Duns Number:016898496
Device Description: Dispoz-A-Bag, Leg Bag with Flip-Flo Drainage Valve, Large (32oz), Each kit includes 4 Leg Dispoz-A-Bag, Leg Bag with Flip-Flo Drainage Valve, Large (32oz), Each kit includes 4 Leg Bags and 2 Fabric Leg Straps.
Catalog Number
150432
Brand Name
Leg Bag
Version/Model Number
150432
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
-
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
5f9fdaaa-e9c5-43eb-97ec-d9976eb2d4a7
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
October 21, 2020
Package DI Number
10801741080668
Quantity per Package
12
Contains DI Package
00801741080661
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 |