Pole Mount Instant Flow Valve - On/Off control of oxygen flow when using a - INSTRUMENTATION INDUSTRIES, INCORPORATED

Duns Number:053146767

Device Description: On/Off control of oxygen flow when using a resuscitator bag:For use with hyperinflation ba 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.

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More Product Details

Catalog Number

BE 3000-Pa

Brand Name

Pole Mount Instant Flow Valve

Version/Model Number

BE 3000-PA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K970959

Product Code Details

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Device Record Status

Public Device Record Key

756483ec-d83c-4d65-becc-57d0737d3445

Public Version Date

November 04, 2019

Public Version Number

5

DI Record Publish Date

October 01, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSTRUMENTATION INDUSTRIES, INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 229
2 A medical device with a moderate to high risk that requires special controls. 71