Catalog Number

94023

Brand Name

PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160

Version/Model Number

Pneumatic Respiration Chest Bellows

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

MWI

Product Code Name

Monitor, physiological, patient (without arrhythmia detection or alarms)

Public Device Record Key

857fbd6e-9054-4a78-8f25-f5260d18124f

Public Version Date

August 22, 2022

Public Version Number

4

DI Record Publish Date

May 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-