Duns Number:961027315
Device Description: Smart-Read Biological Indicator Test Pack
Catalog Number
T40329SR
Brand Name
CARDINAL HEALTH
Version/Model Number
T40329SR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2025
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
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
92b0bdc7-060e-474b-86e4-26277e0779c1
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
October 04, 2016
Package DI Number
20885380030915
Quantity per Package
25
Contains DI Package
10885380030918
Package Discontinue Date
January 01, 2025
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |