Duns Number:961027315
Device Description: DIALYSIS TRAY
Catalog Number
03-5329B
Brand Name
CARDINAL HEALTH
Version/Model Number
03-5329B
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
PEV
Product Code Name
Dialysis administration kit
Public Device Record Key
67b15730-28db-4bd7-b023-d4fcef2d9b2d
Public Version Date
July 01, 2022
Public Version Number
1
DI Record Publish Date
June 23, 2022
Package DI Number
50195594712455
Quantity per Package
30
Contains DI Package
10195594712457
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 |