Duns Number:961027315
Device Description: Trumpet Valve w/ Single Spike and no Probe
Catalog Number
ASC1220
Brand Name
CARDINAL HEALTH
Version/Model Number
ASC1220
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 12, 2021
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
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
b42aa82f-f069-46eb-b120-467c96e789de
Public Version Date
August 13, 2021
Public Version Number
6
DI Record Publish Date
July 22, 2016
Package DI Number
50885380107847
Quantity per Package
12
Contains DI Package
10885380107849
Package Discontinue Date
August 12, 2021
Package Status
Not 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 |