Device
POLYSITE Pressure injectable Implantable Infusion Port
Manufacturer
Vygon Corporation
Vygon Corporation
Model: 4018PI
Catalog: 4018PI
DI: 00849884007374
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
POLYSITE Pressure injectable Implantable Infusion Port
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f42fd4e6-9446-4ae2-980e-01853a3a0895
Distribution Status:
In Commercial Distribution
DUNS Number:
120818216
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
30849884007375
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
30
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
20849884007378
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
20849884007378
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
1
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00849884007374
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00849884007374
Item #3 - Device ID Type:
Primary
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 61494
Name: Vascular port/catheter
Definition:
A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.
FDA Product Codes
LJT
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Premarket Submissions
Submission Number:
K122834
Supplement Number:
000