Catalog Number

a55108

Brand Name

Percussionaire

Version/Model Number

A55108

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 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

0a63a5ae-6cff-4887-b862-298ea3d2612c

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

June 13, 2017

Package DI Number

10849436000348

Quantity per Package

2

Contains DI Package

00849436000341

Package Discontinue Date

February 26, 2020

Package Status

Not in Commercial Distribution

Package Type

Box