Duns Number:825673239
Device Description: AMSure® Urinary Drainage BagPear ShapeCONTENTS:One each 2000mL drainage bag equipped with: AMSure® Urinary Drainage BagPear ShapeCONTENTS:One each 2000mL drainage bag equipped with: Large anti-reflux chamber, Universal hook hanger, Bed sheet clamp, T-valve drainage outlet, AMSecure® needleless sampling adapter
Catalog Number
AS32200
Brand Name
AMSure® Urinary Drainage 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
KNX
Product Code Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Public Device Record Key
ad10ee79-fd7e-48ea-9959-157744fddb9d
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
40704411003107
Quantity per Package
20
Contains DI Package
10704411003106
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 |