Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name: Arthrex® FDA UDI
Generic Name: Cardiac ablation system irrigation tubing set FDA UDI
Device Name: TUBING, EXTENSION 6FT. (20-BOX) FDA UDI
Model / Reference: AR-6220 FDA UDI
Description: TUBING, EXTENSION 6FT. (20-BOX) FDA UDI

Identifiers

Catalog Number: AR-6220 FDA UDI
Primary DI / UDI-DI: 00888867039032 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Cardiac ablation system irrigation tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 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

FDA UDI

Category: Cardiac ablation system irrigation tubing set

Arthrex® by Arthrex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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CoolFlow — Biosense Webster Inc · Class II
Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class II

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: Arthrex, Inc.

Sources (1)

FDA UDI 4fc7ac17-e3eb-4216-a1ce-2357014e2854 35 fields · synced Jun 8, 2026