Rail Mount Instant Flow Valve

Basic Information

• Brand Name: Rail Mount Instant Flow Valve
• Primary DI: M996BE3000RS0
• Version / Model: BE 3000-RS
• Catalog Number: BE 3000-RS
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Labeler DUNS: 053146767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-01
• Public Version: 5
• Public Version Date: 2019-11-04
• Public Version Status: Update
• Public Device Record Key: 4c40af64-e8d5-4876-9472-635fed54ff22

Device Description

On/Off control of oxygen flow when using a resuscitator bag: For use with hyperinflation bag (not included) weighing 3 ounces to 4 pounds (90-1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing the bag on the arm of the valve. Immediate oxygen flow is provided when bag is lifted from the arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.

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
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	868.5915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64445	Respiratory gas output switch	A non-powered device connected between a respiratory gas (e.g. oxygen) supply (e.g., wall outlet, cylinder) and one or more delivery devices (e.g., tubing, masks) intended to enable a user to turn the gas supply on and off, or to switch between alternative delivery devices; it is not an anaesthesia gas manifold. The manual switching component may be in the form of a lever that holds the delivery device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M996BE3000RS0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K970959	000