Duns Number:961027315
Device Description: ENDOVASCULAR AUX PACK
Catalog Number
SCV54EAWMH
Brand Name
CARDINAL HEALTH
Version/Model Number
SCV54EAWMH
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
OEQ
Product Code Name
Angiography/angioplasty kit
Public Device Record Key
37a896f2-ee40-4025-8266-1789ff54a709
Public Version Date
April 23, 2021
Public Version Number
1
DI Record Publish Date
April 15, 2021
Package DI Number
50195594977366
Quantity per Package
3
Contains DI Package
10195594977368
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 |