Duns Number:961027315
Device Description: 62657 CARDIAC CATH MOTT
Catalog Number
SRI0VCCUMB
Brand Name
CARDINAL HEALTH
Version/Model Number
SRI0VCCUMB
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OES
Product Code Name
Cardiac catheterization kit
Public Device Record Key
641fbc24-c988-4586-a28e-5d70a502719d
Public Version Date
July 20, 2018
Public Version Number
3
DI Record Publish Date
July 13, 2016
Package DI Number
50885425721373
Quantity per Package
4
Contains DI Package
10885425721375
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 |