Duns Number:961027315
Device Description: Standard Night Drainage Bag, 2,000mL
Catalog Number
ND2000R
Brand Name
CARDINAL HEALTH
Version/Model Number
ND2000R
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
5c9e55ef-c536-488e-855f-4048205d5a7d
Public Version Date
April 07, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2016
Package DI Number
50885380126312
Quantity per Package
20
Contains DI Package
10885380126314
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |