PSI-TEC Filter Connecting Tubing

FDA UDI

Class I (US FDA UDI)

by Mentor Texas LP

Identity

Trade Name: PSI-TEC Filter Connecting Tubing FDA UDI
Generic Name: Suction/irrigation tubing, single-use FDA UDI
Device Name: PSI-TEC Filter Connecting Tubing FDA UDI
Model / Reference: PT-5558-F FDA UDI
Description: PSI-TEC Filter Connecting Tubing FDA UDI

Identifiers

Catalog Number: PT-5558-F FDA UDI
Primary DI / UDI-DI: 00081317023517 FDA UDI
FDA Product Code: KGZ FDA UDI
GMDN Term: Suction/irrigation tubing, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Suction/irrigation tubing, single-use

PSI-TEC Filter Connecting Tubing by Mentor Texas LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suction/irrigation tubing, single-use.

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AMSure® Suction Connecting Tube with Pre-Attached Yankauer — AMSINO INTERNATIONAL, INC. · Class II
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ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
Bioseal Inc. — BIOSEAL · Class I
Conneting tube — Grena (Qingdao) Medical Devices Ltd. · Class I
Suction Tube Ch 24, 350 cm — Dispo Medical B.V. · Class I
Bioseal Inc. — BIOSEAL · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Mentor Texas LP

Sources (1)

FDA UDI 94b70c22-7463-46ab-b126-b9095ddf43ac 35 fields · synced May 31, 2026