Duns Number:961027315
Device Description: NPWT Black Foam Dressing Kit Occlusion Detection - LARGE x15
Catalog Number
48-1700-15
Brand Name
CARDINAL HEALTH
Version/Model Number
48-1700-15
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"
-
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
OMP
Product Code Name
negative pressure wound therapy Powered suction pump
Public Device Record Key
51c2e9e0-57b3-4df8-a0c1-5b8ae13f70c7
Public Version Date
October 19, 2020
Public Version Number
5
DI Record Publish Date
May 30, 2018
Package DI Number
50885380153073
Quantity per Package
15
Contains DI Package
10885380153075
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 |