Duns Number:961027315
Device Description: JP 400CC KIT W/10FR SIL W/TRO
Catalog Number
SU130-1080
Brand Name
CARDINAL HEALTH
Version/Model Number
SU130-1080
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
October 30, 2024
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
GCY
Product Code Name
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Public Device Record Key
8fe659be-64d0-4484-a7fb-83b993f0677b
Public Version Date
August 03, 2021
Public Version Number
6
DI Record Publish Date
May 10, 2018
Package DI Number
50630140020986
Quantity per Package
10
Contains DI Package
10630140020988
Package Discontinue Date
October 30, 2024
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 |