Duns Number:961027315
Device Description: BLOOD CULTURE KIT
Catalog Number
LABV25102H
Brand Name
CARDINAL HEALTH
Version/Model Number
LABV25102H
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
4997adcd-7749-4c55-a771-87ca8789c52c
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
June 24, 2016
Package DI Number
50885425969843
Quantity per Package
25
Contains DI Package
10885425969845
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 |