Duns Number:016898496
Device Description: Dispoz-A-Bag Leg Bag, Large 32oz (946cc/mL)
Catalog Number
150103
Brand Name
Leg Bag
Version/Model Number
150103
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
KNX
Product Code Name
COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
Public Device Record Key
b0568fc8-5134-4a78-8380-843f4db0460a
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
September 22, 2020
Package DI Number
20801741050736
Quantity per Package
4
Contains DI Package
10801741050739
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 |