Duns Number:961027315
Device Description: KIT, BLOOD CULTURE
Catalog Number
LABHB0183A
Brand Name
CARDINAL HEALTH
Version/Model Number
LABHB0183A
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
OIB
Product Code Name
Blood and urine collection kit (excludes hiv testing)
Public Device Record Key
b5809834-8f5f-4909-9d14-d9de5f0c2d6e
Public Version Date
July 20, 2018
Public Version Number
3
DI Record Publish Date
July 26, 2016
Package DI Number
50885425598586
Quantity per Package
25
Contains DI Package
10885425598588
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 |