Duns Number:961027315
Device Description: OPEN HEART KIT
Catalog Number
PCVSOHMIA
Brand Name
CARDINAL HEALTH
Version/Model Number
PCVSOHMIA
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
2692a916-1978-46ae-b305-e794366e290a
Public Version Date
July 20, 2018
Public Version Number
3
DI Record Publish Date
August 06, 2015
Package DI Number
50885425969416
Quantity per Package
1
Contains DI Package
00885425969411
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 |