Duns Number:961027315
Device Description: JP CHAN DRN SIL RND 15FR FULL W/TRO
Catalog Number
JP-2189
Brand Name
JACKSON-PRATT
Version/Model Number
JP-2189
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGZ
Product Code Name
ACCESSORIES, CATHETER
Public Device Record Key
56e4705f-ea90-4267-ad5e-9d82341aed81
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
December 09, 2021
Package DI Number
20885380182447
Quantity per Package
10
Contains DI Package
10885380182440
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 |