Rail Mount Instant Flow Valve

FDA UDI

Class II (US FDA UDI)

by Instrumentation Industries, Incorporated

Identity

Trade Name: Rail Mount Instant Flow Valve FDA UDI
Generic Name: Respiratory gas output switch FDA UDI
Device Name: 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. FDA UDI
Model / Reference: BE 3000-RA FDA UDI
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. FDA UDI

Identifiers

Catalog Number: BE 3000-RA FDA UDI
Primary DI / UDI-DI: M996BE3000RA0 FDA UDI
510(k) Number: K970959 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Respiratory gas output switch FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5915 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Respiratory gas output switch

Rail Mount Instant Flow Valve by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Respiratory gas output switch.

Wall Mount Bracket for Instant Flow Valves — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
Flowmeter Mount Instant Flow Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
CB 23 Flowmeter / Air Compressor Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
Pole Mount Instant Flow Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
CB 23-1 Flowmeter / Air Compressor Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
Pole Mount Instant Flow Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
Short Arm Flowmeter Mount Instant Flow Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
SC 603A O2 Flow Selector Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I

Cleared under the same submission

K970959 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Instrumentation Industries, Incorporated

Sources (1)

FDA UDI 6b41ea95-b687-4827-9a4f-4f4c77bae570 36 fields · synced May 30, 2026