Duns Number:961027315
Device Description: JP CHAN DRN SIL RND 19FR FULL W/TRO
Catalog Number
JP-2191
Brand Name
JACKSON-PRATT
Version/Model Number
JP-2191
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 30, 2025
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
4111ddb9-d9cd-4129-9a72-418e287ae7ca
Public Version Date
March 08, 2022
Public Version Number
3
DI Record Publish Date
June 11, 2019
Package DI Number
50885380020382
Quantity per Package
8
Contains DI Package
20885380020381
Package Discontinue Date
June 30, 2025
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 |