Duns Number:079506014
Device Description: 3F X 55CM SINGLE LUMEN JET POWER INJECTABLE PICC
Catalog Number
JT05035501
Brand Name
3F X 55CM SINGLE LUMEN POWER PICC
Version/Model Number
JT05035501
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
LJS
Product Code Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Public Device Record Key
939ac5a8-0d6a-4d04-b170-62d26596d6fb
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
July 20, 2015
Package DI Number
50810988020588
Quantity per Package
10
Contains DI Package
00810988020583
Package Discontinue Date
May 14, 2018
Package Status
Not 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 |