BE 148-5-3.5 Gauge Clamp

Basic Information

• Brand Name: BE 148-5-3.5 Gauge Clamp
• Primary DI: M996BE1485350
• Version / Model: BE 148-5-3.5
• Catalog Number: BE 148-5-3.5
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Labeler DUNS: 053146767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 303f1042-2d51-421e-9692-46368f6b96f8

Device Description

The BE 148-5-3.5 Gauge Clamp is an accessory to the NS Series Vacuum/Pressure Gauges. The BE 148-5-3.5 is used to securely mount Gauges with a rear 1/4" NPT thread to medical equipment such as poles, incubators, ventilators, etc. The BE 148-5-3.5 gauge clamp works with equipment that requires a clamp having a 2-1/2" to 3-1/2" opening.

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	868.2600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46634	Airway pressure monitor, non-powered	A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M996BE1485350	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081778	000