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Polysite

FDA UDI

Class II (US FDA UDI)

by Perouse Medical

Identity

Trade Name
Polysite FDA UDI
Generic Name
Vascular port/catheter FDA UDI
Device Name
POLYSITE Implantable Infusion Port FDA UDI
Model / Reference
2016C FDA UDI
Description
POLYSITE Implantable Infusion Port FDA UDI

Identifiers

Primary DI / UDI-DI
13661234011558 FDA UDI
510(k) Number
K122834 FDA UDI
FDA Product Code
LJT FDA UDI
GMDN Term
Vascular port/catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5965 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Polysite by Perouse Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K122834 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Perouse Medical

Sources (1)

  • FDA UDI 83027af4-dd3b-4ee5-96a1-d52eecd00b77 35 fields · synced May 30, 2026