Hyperinflation - Disposable Hyperinflation System, 1/2L Breathing - WESTMED, INC.

Duns Number:092673953

Device Description: Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Line Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines, Series 900 Infant Mask

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More Product Details

Catalog Number

-

Brand Name

Hyperinflation

Version/Model Number

7-N7905-I

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

K932709,K932709

Product Code Details

Product Code

BZR

Product Code Name

Mixer, Breathing Gases, Anesthesia Inhalation

Device Record Status

Public Device Record Key

c5cf78a2-0ed8-441e-9dac-ebb4d6d17820

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

20709078063859

Quantity per Package

12

Contains DI Package

00709078063855

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"WESTMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 746
2 A medical device with a moderate to high risk that requires special controls. 320