Duns Number:961027315
Device Description: INSUFFLATION TUBING SET
Catalog Number
ASU1512
Brand Name
CARDINAL HEALTH
Version/Model Number
ASU1512
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 19, 2025
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
NKC
Product Code Name
Tubing/tubing with filter, insufflation, laparoscopic
Public Device Record Key
ce7085c7-fed4-4101-9117-fd05fb3d90ae
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
July 22, 2016
Package DI Number
50630140038059
Quantity per Package
10
Contains DI Package
10630140038051
Package Discontinue Date
February 19, 2025
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 |