Terumo Cardiovascular Systems

FDA UDI

Class II (US FDA UDI)

by Med Michigan Holdings Llc

Identity

Trade Name: Terumo Cardiovascular Systems FDA UDI
Generic Name: Suction system catheter, general-purpose FDA UDI
Device Name: Rigid cardiac sucker, fluted tip, 1/4" connector, 13" length FDA UDI
Model / Reference: 4300S FDA UDI
Description: Rigid cardiac sucker, fluted tip, 1/4" connector, 13" length FDA UDI

Identifiers

Catalog Number: 4300S FDA UDI
Primary DI / UDI-DI: 00817278011399 FDA UDI
FDA Product Code: GCX FDA UDI
GMDN Term: Suction system catheter, general-purpose FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6740 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Suction system catheter, general-purpose

Terumo Cardiovascular Systems by Med Michigan Holdings Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suction system catheter, general-purpose.

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Gen2 — SURGIX MEDICAL LLC · Class II
GP General Purpose Drainage Catheter — Uresil Corp. · Class I
Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
Gen2 — SURGIX MEDICAL LLC · Class II
Surgical Direct — SURGICAL DIRECT, INC. · 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 II	Pending data

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Manufacturer

Manufacturer: Med Michigan Holdings Llc

Sources (1)

FDA UDI 7d89c7eb-6006-421b-ba4f-fc4ffcd7136c 34 fields · synced Jun 8, 2026