Duns Number:961027315
Device Description: JP 100CC KT W/7MM FULL PERF DRN W/T
Catalog Number
SU130-1370
Brand Name
CARDINAL HEALTH
Version/Model Number
SU130-1370
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
GCY
Product Code Name
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Public Device Record Key
a0632127-0059-47b5-ba5c-2f388a7679a1
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
May 01, 2018
Package DI Number
50885380039896
Quantity per Package
10
Contains DI Package
10885380039898
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 |