Duns Number:112164780
Device Description: NPWT SVED/ CATALYST Global Power Adapter
Catalog Number
47-9200
Brand Name
CARDINAL HEALTH
Version/Model Number
47-9200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
OMP
Product Code Name
negative pressure wound therapy Powered suction pump
Public Device Record Key
f173a44d-fab0-40d3-9415-05ccb4dae402
Public Version Date
August 12, 2021
Public Version Number
1
DI Record Publish Date
August 04, 2021
Package DI Number
50885380180505
Quantity per Package
1
Contains DI Package
10885380180507
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 | 81 |
2 | A medical device with a moderate to high risk that requires special controls. | 111 |