BE 150-5LF Test Lung

Basic Information

• Brand Name: BE 150-5LF Test Lung
• Primary DI: M996BE1505LF0
• Version / Model: BE 150-5LF
• Catalog Number: BE 150-5LF
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Labeler DUNS: 053146767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-30
• Public Version: 3
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: bac893b6-d47c-4438-87ce-1cc1f13da5df

Device Description

BE 150-5LF Test Lung has a 22mm I.D. connection and a 750 ml capacity; Not made with natural rubber latex. Not for patient use.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTC	Bag, Reservoir	Anesthesiology	868.5320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12408	Lung physical simulator	A mechanical device intended to simulate/mimic the human lung(s) by imitating its physical properties. This device, commonly known as a test lung, may be a simple ventilation bag filled with foam rubber, or a complicated device, usually mechanical, that can be adjusted to imitate, e.g., change in compliance, airway restrictions, lung perforation. It is intended to be used by a healthcare provider in a clinical setting for the purpose of, e.g., maintenance, testing, user control of a ventilator and for the education of clinical staff.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M996BE1505LF0	HIBCC
Package	M996BE1505LF1	HIBCC	Ziplock poly bag	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]