Wall Mount Bracket for Instant Flow Valves BE 3000-WM

GUDID M996BE3000WM0

Bracket attaches to the wall, and to rail-mounted versions of Instant Flow Valves for 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 IDM996BE3000WM0
NIH Device Record Keyb842d646-fe08-4a52-896a-0ec42ba97878
Commercial Distribution StatusIn Commercial Distribution
Brand NameWall Mount Bracket for Instant Flow Valves
Version Model NumberBE 3000-WM
Catalog NumberBE 3000-WM
Company DUNS053146767
Company NameINSTRUMENTATION INDUSTRIES, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone412-854-1133
Emailraqa@iiimedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM996BE3000WM0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-04
Device Publish Date2015-10-01

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