Duns Number:825673239
Device Description: AMSure® Urinary Leg BagLarge - 900 mL, Flip ValveCONTENTS:One each 900 mL leg bag equipped AMSure® Urinary Leg BagLarge - 900 mL, Flip ValveCONTENTS:One each 900 mL leg bag equipped with:Flip valve drainage outletAnti-reflux valveTwo latex-free straps
Catalog Number
AS309F
Brand Name
AMSure® Urinary Leg Bag
Version/Model Number
1
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
FAQ
Product Code Name
Bag, Urine Collection, Leg, For External Use, Sterile
Public Device Record Key
fb596c81-c7bf-4b55-8189-cdc17620c602
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
May 30, 2018
Package DI Number
40704411008287
Quantity per Package
48
Contains DI Package
10704411008286
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |