Arrow

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: ARROW FDA UDI
Generic Name: Central venous catheterization kit, short-term FDA UDI
Device Name: POLYSITE Pressure Injectable Implantable Infusion Port, Micro port size, without silicone filled suture holes & 6F Chronoflex PU catheter FDA UDI
Model / Reference: IPN033650 FDA UDI
Description: POLYSITE Pressure Injectable Implantable Infusion Port, Micro port size, without silicone filled suture holes & 6F Chronoflex PU catheter FDA UDI

Identifiers

Catalog Number: 2016PI FDA UDI
Primary DI / UDI-DI: 10801902189520 FDA UDI
510(k) Number: K122834 FDA UDI
FDA Product Code: LJT FDA UDI
GMDN Term: Central venous catheterization kit, short-term FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5965 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Central venous catheterization kit, short-term

Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K122834 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI e07e8e52-cd29-4b04-8b1d-486f9f611167 36 fields · synced May 30, 2026