Duns Number:079506014
Catalog Number
JT011553201
Brand Name
15.5F X 32CM JET FLOW LT CATHETER
Version/Model Number
JT011553201
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
MSD
Product Code Name
Catheter, Hemodialysis, Implanted
Public Device Record Key
aeaa086b-19ef-44c3-8070-bb9d0a389f94
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
July 20, 2015
Package DI Number
50810988020021
Quantity per Package
5
Contains DI Package
00810988020026
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 63 |