BE 30-142

Basic Information

• Brand Name: BE 30-142
• Primary DI: M996BE301420
• Version / Model: BE 30-142
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Labeler DUNS: 053146767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-13
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a5b2e9e2-ba27-4fcb-b688-98f984724b23

Device Description

The reusable BE 30-142 is designed for use with ventilators, anesthesia machines, resuscitators, and other systems where PEEP or CPAP is required. A threshold-like resistance is applied after active exhalation. The PEEP valve prevents the exhalation pressure from dropping below a pre-determined value. PEEP ranges are adjustable from 3 to 20cm of water. Maximum PEEP can vary +/-10%. Objectives of PEEP therapy: 1) increase functional residual capacity by maintaining a positive pressure throughout the ventilatory cycle - improves gas distribution, 2) aid in the prevention of atelectasis via aveolar stinting, 3) decrease in the inspired oxygen fraction (FiO2) is an advantage, 4) help in the stabilization of flail chest condition, and 5) monitor tidal volume by connecting a spirometer to the outlet port.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• 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: Yes
• Sterilization Methods: ["High-level Disinfectant", "Ethylene Oxide", "Radiation Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	868.5965	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14337	PEEP valve, reusable	A non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M996BE301420	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K963347	000