BE 30-115-BL Low Resistance Exhalation Valve - This reusable exhalation valve is designed for - INSTRUMENTATION INDUSTRIES, INCORPORATED

Duns Number:053146767

Device Description: This reusable exhalation valve is designed for use with ventilators. The exhalation valve This reusable exhalation valve is designed for use with ventilators. The exhalation valve prevents the inspired gases from escaping through the passage that will be made available to expired gases via an inflatable balloon. Also, the re-breathing of the expired gases are prevented by the balloon action.

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More Product Details

Catalog Number

-

Brand Name

BE 30-115-BL Low Resistance Exhalation Valve

Version/Model Number

BE 30-115-BL

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

K980725

Product Code Details

Product Code

CBP

Product Code Name

Valve, Non-Rebreathing

Device Record Status

Public Device Record Key

55e2f9ab-d1bd-4cf6-962e-59c06829a783

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 11, 2017

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