Duns Number:961027315
Device Description: UA Control Tube Normal -90mL
Catalog Number
CHUA115
Brand Name
CARDINAL HEALTH
Version/Model Number
CHUA115
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 10, 2020
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Yes
FDA Premarket Submission
-
Product Code
JJW
Product Code Name
Urinalysis controls (assayed and unassayed)
Public Device Record Key
622ccadc-17bb-4237-960d-dcfdeae3813f
Public Version Date
August 10, 2020
Public Version Number
3
DI Record Publish Date
May 16, 2019
Package DI Number
50885380151901
Quantity per Package
6
Contains DI Package
10885380151903
Package Discontinue Date
August 10, 2020
Package Status
Not in Commercial Distribution
Package Type
BOX
| 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 |