Duns Number:016898496
Device Description: Latex Dispoz-A-Bag Leg Bag, Medium (19oz), with Flip-Flo Drainage Valve, 18" Latex Extensi Latex Dispoz-A-Bag Leg Bag, Medium (19oz), with Flip-Flo Drainage Valve, 18" Latex Extension Tubing, 4-1/2" Drainage Tubing, and Two Latex Leg Straps
Catalog Number
651919
Brand Name
Leg Bag
Version/Model Number
651919
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
FAQ
Product Code Name
BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
Public Device Record Key
b18a49a2-6d01-46a6-9d86-a5a51dfc2259
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2020
Package DI Number
10801741051002
Quantity per Package
50
Contains DI Package
00801741051005
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 |