Duns Number:194550042
Device Description: SPECIMEN KIT, BONE MARROW, PATH CON
Catalog Number
CA1475
Brand Name
CARDINAL HEALTH
Version/Model Number
CA1475
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"
Yes
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
GAA
Product Code Name
NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
Public Device Record Key
2ee5ed9f-af21-41f6-b771-6d5e8e186342
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
April 12, 2019
Package DI Number
50885380122055
Quantity per Package
5
Contains DI Package
10885380122057
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 |