Duns Number:002348191
Device Description: POLYSITE Pressure Injectable Implantable Infusion Port, Micro port size, without silicone POLYSITE Pressure Injectable Implantable Infusion Port, Micro port size, without silicone filled suture holes & 6F Chronoflex PU catheter
Catalog Number
2016PI
Brand Name
ARROW
Version/Model Number
IPN033650
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122834,K122834
Product Code
LJT
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Public Device Record Key
e07e8e52-cd29-4b04-8b1d-486f9f611167
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
March 10, 2021
Package DI Number
20801902189527
Quantity per Package
1
Contains DI Package
10801902189520
Package Discontinue Date
June 14, 2022
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |