Duns Number:961027315
Device Description: STERILE OPEN HEART PACK
Catalog Number
SCV23OHNCL
Brand Name
CARDINAL HEALTH
Version/Model Number
SCV23OHNCL
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
OEZ
Product Code Name
Cardiovascular procedure kit
Public Device Record Key
5defb0b0-fe56-4b96-bd8e-9438388154ee
Public Version Date
July 17, 2018
Public Version Number
3
DI Record Publish Date
August 14, 2015
Package DI Number
50885425939198
Quantity per Package
2
Contains DI Package
00885425939193
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 |