Duns Number:961027315
Device Description: JP 3-SPRING RES W/15FR PVC DRAIN/TR
Catalog Number
SU130-403D
Brand Name
CARDINAL HEALTH
Version/Model Number
SU130-403D
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
GCY
Product Code Name
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Public Device Record Key
0e8a5fb9-bf3a-4de5-aa73-fa4b4fad5709
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
October 16, 2019
Package DI Number
20192253016434
Quantity per Package
6
Contains DI Package
10192253016437
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |