Duns Number:963281709
Device Description: Invisiport 4.4 Fr Convenience Kit Contents:Invisiport 4.4Fr Vascular Access Port with Cath Invisiport 4.4 Fr Convenience Kit Contents:Invisiport 4.4Fr Vascular Access Port with Catheter (Not made with natural rubber latex);Microaccess Tear-Away Introducer Set;MicroIntroducer needle;Microguidewire;20 Gauge, 1.5 inch, Non-Coring Access Needle
Catalog Number
2000
Brand Name
Invisiport 4.4 Fr
Version/Model Number
2000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 11, 2018
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
LJT
Product Code Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Public Device Record Key
244d1669-9655-4942-a22a-48ef8a836faa
Public Version Date
February 27, 2020
Public Version Number
4
DI Record Publish Date
March 19, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |