Hyperinflation - Hyperinflation System, 1/2L Bag (not made with - WESTMED, INC.

Duns Number:092673953

Device Description: Hyperinflation System, 1/2L Bag (not made with latex), 7' O2 and Pressure Lines, 40 cm H2O Hyperinflation System, 1/2L Bag (not made with latex), 7' O2 and Pressure Lines, 40 cm H2O pop-valve

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More Product Details

Catalog Number

-

Brand Name

Hyperinflation

Version/Model Number

900 000 627

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

d63b153c-c6d1-489f-8f08-1b1ebec7250c

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

January 31, 2020

Additional Identifiers

Package DI Number

05707480137510

Quantity per Package

12

Contains DI Package

05707480137503

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