Duns Number:002348191
Device Description: POLYSITE Implantable Infusion Port, Standard port size, with silicone filled suture holes
Catalog Number
4018SC
Brand Name
ARROW
Version/Model Number
IPN033677
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
11a9ee03-614a-4b5d-850b-b1ae02471090
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
April 04, 2022
Package DI Number
20801902189619
Quantity per Package
1
Contains DI Package
10801902189612
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 |