Duns Number:961027315
Device Description: Cardinal Health NPWT Irrigation Tubing with SpeedConnect
Catalog Number
47-6000
Brand Name
CARDINAL HEALTH
Version/Model Number
47-6000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 15, 2022
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
OMP
Product Code Name
negative pressure wound therapy Powered suction pump
Public Device Record Key
a5b62e5a-fe95-404d-b5db-163ca6cdc638
Public Version Date
April 15, 2022
Public Version Number
8
DI Record Publish Date
July 12, 2016
Package DI Number
50885380097629
Quantity per Package
5
Contains DI Package
10885380097621
Package Discontinue Date
April 15, 2022
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 |