Duns Number:961027315
Device Description: JP 3-SPRING RES W/SILICONE ADAPTERS
Catalog Number
SU130-475
Brand Name
CARDINAL HEALTH
Version/Model Number
SU130-475
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
0249b022-7afc-4a71-b9db-13dc15485e70
Public Version Date
October 24, 2019
Public Version Number
1
DI Record Publish Date
October 16, 2019
Package DI Number
20192253016465
Quantity per Package
6
Contains DI Package
10192253016468
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 |