SuperFlow Tubing Set

FDA UDI

Class II (US FDA UDI)

by Armm Inc.

Identity

Trade Name: SuperFlow Tubing Set FDA UDI
Generic Name: Surgical irrigation/aspiration tubing set FDA UDI
Device Name: Suction / Irrigation Wye Tubing Set with Valves FDA UDI
Model / Reference: 21405 FDA UDI
Description: Suction / Irrigation Wye Tubing Set with Valves FDA UDI

Identifiers

Primary DI / UDI-DI: 10850082007025 FDA UDI
510(k) Number: K923201 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Surgical irrigation/aspiration tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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: Surgical irrigation/aspiration tubing set

SuperFlow Tubing Set by Armm Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation/aspiration tubing set.

LAMIS Tubing — Mentor Texas LP · Class I
Aspiration Tubing — BLACK & BLACK SURGICAL, INC. · Class II
MB ULTRA-LIMP TUBING — The Wells Johnson Company · Class II
INFILTRATION TUBING — BLACK & BLACK SURGICAL, INC. · Class II
Autofuse Tubing — Mentor Texas LP · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class II
ENDOFLOW II - PROBES - 4 holes diam.5 inch — Promepla · Class I
Hysteroscopy set 2 spikes — Promepla · Class II

Cleared under the same submission

K923201 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: Armm Inc.

Sources (1)

FDA UDI a69ef648-9c05-4177-bbd2-0e23e05ad2ad 35 fields · synced May 30, 2026