Disposable Respiratory Circuits

FDA UDI

Class I (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name: Disposable Respiratory Circuits FDA UDI
Generic Name: Anaesthesia breathing circuit, single-use FDA UDI
Device Name: Anesthesia Circuit, Pedi-Lim, 60", GSE w/CAP. GSL, B/V Filters, 2L Not Made With Latex Bag FDA UDI
Model / Reference: 6754 FDA UDI
Description: Anesthesia Circuit, Pedi-Lim, 60", GSE w/CAP. GSL, B/V Filters, 2L Not Made With Latex Bag FDA UDI

Identifiers

Primary DI / UDI-DI: 00709078011627 FDA UDI
FDA Product Code: OFP FDA UDI
GMDN Term: Anaesthesia breathing circuit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Anaesthesia breathing circuit, single-use

Disposable Respiratory Circuits by Westmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Anaesthesia breathing circuit, single-use.

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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

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: Westmed, Inc.

Sources (1)

FDA UDI e1cc9934-a716-4664-abf3-dc8b212e80c2 33 fields · synced Jun 8, 2026