Duns Number:961027315
Device Description: DRAIN JACKSON PRATT EXT63/4 1
Catalog Number
SU130-1315
Brand Name
CARDINAL HEALTH
Version/Model Number
SU130-1315
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
GCD
Product Code Name
CONNECTOR, CATHETER
Public Device Record Key
bcfe80ac-aa75-4930-909f-befae45b7bd1
Public Version Date
June 04, 2020
Public Version Number
1
DI Record Publish Date
May 27, 2020
Package DI Number
20192253022381
Quantity per Package
10
Contains DI Package
10192253022384
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 |