BE 150-5G Test Lung

FDA UDI

Class I (US FDA UDI)

by Instrumentation Industries, Incorporated

Identity

Trade Name: BE 150-5G Test Lung FDA UDI
Generic Name: Lung physical simulator FDA UDI
Device Name: BE 150-5G Test Lung has a 22mm I.D. connection and a 1 liter capacity; Not made with natural rubber latex. Not for patient use. FDA UDI
Model / Reference: BE 150-5G FDA UDI
Description: BE 150-5G Test Lung has a 22mm I.D. connection and a 1 liter capacity; Not made with natural rubber latex. Not for patient use. FDA UDI

Identifiers

Catalog Number: BE 150-5G FDA UDI
Primary DI / UDI-DI: M996BE1505G0 FDA UDI
FDA Product Code: BTC FDA UDI
GMDN Term: Lung physical simulator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Lung physical simulator

BE 150-5G Test Lung by Instrumentation Industries, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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FISHER & PAYKEL HEALTHCARE — FISHER & PAYKEL HEALTHCARE, INC. · 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 I	Pending data

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Manufacturer

Manufacturer: Instrumentation Industries, Incorporated

Sources (1)

FDA UDI 8f6b3804-baee-4a3c-ac12-22875efef175 35 fields · synced May 30, 2026