Duns Number:097736867
Device Description: TJL Low Profile HP PUR Kit with 6.6F x 750 mm Attachable Polyurethane Catheter
Catalog Number
-
Brand Name
Tita Jet Light
Version/Model Number
616.360.8070-HA
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
K072481,K072481
Product Code
LJT
Product Code Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Public Device Record Key
f4315de5-b1f6-43c0-b493-83b860f86122
Public Version Date
March 06, 2020
Public Version Number
1
DI Record Publish Date
February 27, 2020
Package DI Number
07640110980835
Quantity per Package
20
Contains DI Package
07640110985465
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 109 |