Duns Number:961027315
Device Description: DRESSING CHANGE KIT
Catalog Number
03-5370D
Brand Name
CARDINAL HEALTH
Version/Model Number
03-5370D
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
OXQ
Product Code Name
Dressing change tray
Public Device Record Key
5fc13fb7-dd00-44b5-80b3-f4de3856d3bd
Public Version Date
September 06, 2022
Public Version Number
1
DI Record Publish Date
August 29, 2022
Package DI Number
50195594755902
Quantity per Package
50
Contains DI Package
10195594755904
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 |