Catalog Number

A50606-TXP

Brand Name

Percussionaire

Version/Model Number

A50606-TXP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K905234,K905234

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

8091e91f-5bde-4086-807a-595c8d7d3260

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

April 08, 2020

Package DI Number

10849436000614

Quantity per Package

5

Contains DI Package

00849436000617

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case