AccessGUDID - DEVICE: Pole Mount Instant Flow Valve (M996BE3000PS0)

GUDID

Device Identifier (DI) Information

Brand Name: Pole Mount Instant Flow Valve
Version or Model: BE 3000-PS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BE 3000-PS
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996BE3000PS0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTM	Ventilator, Emergency, Manual (Resuscitator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970959	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f662b973-d140-4118-91ef-8dce07e75388
Public Version Date: November 04, 2019
Public Version Number: 5
DI Record Publish Date: October 01, 2015