Catalog Number

890060

Brand Name

Allied Healthcare Products Inc.

Version/Model Number

890060

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

-

Product Code

BXR

Product Code Name

Meter, Airway Pressure (Inspiratory Force)

Public Device Record Key

2a96a1f6-482d-4028-a256-7e609196c5fc

Public Version Date

May 11, 2020

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

40026072011285

Quantity per Package

12

Contains DI Package

00026072011287

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case