Uni-Lim 120" Adult Coaxial Breathing Circuit

FDA UDI

Class II (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name: Uni-Lim 120" Adult Coaxial Breathing Circuit FDA UDI
Generic Name: Anaesthesia breathing circuit, single-use FDA UDI
Device Name: Uni-Lim 120" Adult Coaxial Breathing Circuit 24" Flex Expiratory, GSE, B/V Filter, InLine Mini HMEF, 3L Not made with latex bag, 10' x .060" M/M GSL, 10' x .060" M/F GSL FDA UDI
Model / Reference: 9618 FDA UDI
Description: Uni-Lim 120" Adult Coaxial Breathing Circuit 24" Flex Expiratory, GSE, B/V Filter, InLine Mini HMEF, 3L Not made with latex bag, 10' x .060" M/M GSL, 10' x .060" M/F GSL FDA UDI

Identifiers

Primary DI / UDI-DI: 00709078009433 FDA UDI
510(k) Number: K922492 FDA UDI
FDA Product Code: CAH FDA UDI
OFP FDA UDI
GMDN Term: Anaesthesia breathing circuit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5260 FDA UDI
868.5240 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

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Anaesthesia breathing circuit, single-use

The Uni-Lim 120" Adult Coaxial Breathing Circuit is a comprehensive medical device designed to conduct medical gases from an anesthesia unit/workstation to a patient artificial airway/anaesthesia mask during general anesthesia. It includes breathing tubes, a Y-piece connector, ventilator/ventilation bag and appropriate connectors, carbon dioxide (CO2) absorber, one-way directional valve or adjustable pressure limiting (APL) valve, and may include other features such as a 24" Flex Expiratory, GSE, B/V Filter, InLine Mini HMEF. This single-use device is typically made with latex bag, does not contain MRI Safety Information, and has a manufacturing date prior to the current one. It is used in Anesthesiology for patients undergoing general anesthesia.

Similar devices

Also classified as Anaesthesia breathing circuit, single-use.

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HUDSON RCI — TELEFLEX INCORPORATED · Class I
Vital Signs™ — Airlife, Inc. · Class I
UNIVERSAL FLEX2®BREATHING CIRCUIT & PACK KIT — KING SYSTEMS CORPORATION. · Class I
Vital Signs™ — Airlife, Inc. · Class I
Portex — ICU MEDICAL, INC. · Class I
UNIVERSAL FLEX2® — KING SYSTEMS CORPORATION. · Class I
PEDIATRIC ULTRA FLEX® — KING SYSTEMS CORPORATION. · Class I

Cleared under the same submission

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: Westmed, Inc.

Sources (1)

FDA UDI ffd6adad-3607-4d96-bf56-7878b5947bbb 34 fields · synced Oct 7, 2026