Catalog Number

A50095-DUO

Brand Name

Percussionaire

Version/Model Number

A50095-DUO

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 10, 2019

Issuing Agency

In GS1

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"

-

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

K905236

Product Code

NHJ

Product Code Name

Device, Positive Pressure Breathing, Intermittent

Public Device Record Key

9c533472-5081-4370-a1ba-cf9596ee2847

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

October 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-