Duns Number:961027315
Device Description: CARDINAL HEALTH INSUFFLATION TUBING 10 FT
Catalog Number
C-2025-ST
Brand Name
CARDINAL HEALTH
Version/Model Number
C-2025-ST
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)
-
Over the Counter (OTC)
Yes
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
44dae799-c630-4268-94d7-819b94114dc7
Public Version Date
November 09, 2020
Public Version Number
2
DI Record Publish Date
January 07, 2019
Package DI Number
50885380144446
Quantity per Package
25
Contains DI Package
10885380144448
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 |