Duns Number:097736867
Device Description: T-Port LP HP PUR Kit with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
Catalog Number
-
Brand Name
T-Port
Version/Model Number
616.366.2088-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
K073210,K073210
Product Code
LJT
Product Code Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Public Device Record Key
12a1ea01-c986-417b-bb31-f4106dd25747
Public Version Date
March 06, 2020
Public Version Number
1
DI Record Publish Date
February 27, 2020
Package DI Number
07640110982136
Quantity per Package
20
Contains DI Package
07640110988459
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 |