Catalog Number

A50095-F

Brand Name

Percussionaire

Version/Model Number

A50095-F

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 26, 2020

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,K905236

Product Code

NHJ

Product Code Name

Device, Positive Pressure Breathing, Intermittent

Public Device Record Key

deff65cf-236b-4df9-a635-65c754fe31b5

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

January 18, 2016

Package DI Number

10849436000461

Quantity per Package

10

Contains DI Package

00849436000464

Package Discontinue Date

May 26, 2020

Package Status

Not in Commercial Distribution

Package Type

Case