Duns Number:194550042
Device Description: Blood Culture Collection Kit, Pediatric, Lake District Hospital Only
Catalog Number
CA20925
Brand Name
CARDINAL HEALTH
Version/Model Number
CA20925
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 18, 2021
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)
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
0078339e-7a0b-4017-ba82-a6ba91baba77
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
January 02, 2019
Package DI Number
50885380168572
Quantity per Package
10
Contains DI Package
10885380168574
Package Discontinue Date
February 18, 2021
Package Status
Not 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 |