Rail Mount Instant Flow Valve BE 3000-RS

GUDID M996BE3000RS0

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.

INSTRUMENTATION INDUSTRIES, INCORPORATED

Respiratory gas output switch

• Primary Device ID: M996BE3000RS0
• NIH Device Record Key: 4c40af64-e8d5-4876-9472-635fed54ff22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rail Mount Instant Flow Valve
• Version Model Number: BE 3000-RS
• Catalog Number: BE 3000-RS
• Company DUNS: 053146767
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 412-854-1133
• Email: raqa@iiimedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M996BE3000RS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970959

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-04
• Device Publish Date: 2015-10-01

On-Brand Devices [Rail Mount Instant Flow Valve]

• M996BE3000RS0: On/Off control of oxygen flow when using a resuscitator bag: For use with hyperinflation bag (no
• M996BE3000RA0: On/Off control of oxygen flow when using a resuscitator bag: For use with hyperinflation bag (no