Duns Number:194550042
Device Description: Urine Transfer Kit, Contains Urine Transfer Device and 9mL UA Conical Tube No Additive
Catalog Number
CHBUTK3
Brand Name
CARDINAL HEALTH
Version/Model Number
CHBUTK3
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OIB
Product Code Name
Blood and urine collection kit (excludes HIV testing)
Public Device Record Key
25292b9c-6660-4d64-843b-97a8ff0f9c13
Public Version Date
November 30, 2021
Public Version Number
2
DI Record Publish Date
May 13, 2020
Package DI Number
50885380169432
Quantity per Package
100
Contains DI Package
10885380169434
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 | 467 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |