Duns Number:961027315
Device Description: BLOOD CULTURE KIT HEARTLAND
Catalog Number
LAB4226774
Brand Name
CARDINAL HEALTH
Version/Model Number
LAB4226774
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
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
406f6103-0f83-4ddc-afb4-711ef0ac85ca
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
January 10, 2021
Package DI Number
50888439989234
Quantity per Package
25
Contains DI Package
10888439989236
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 |