Catalog Number

322004000

Brand Name

Disposable Pressure ManometerSingle Patient Use

Version/Model Number

322004000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 27, 2026

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"

Yes

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

CAP

Product Code Name

MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)

Public Device Record Key

1d2f6b3d-710c-4930-8937-6a60b6b8258e

Public Version Date

May 28, 2021

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

05707480036233

Quantity per Package

12

Contains DI Package

05707480020782

Package Discontinue Date

May 27, 2021

Package Status

Not in Commercial Distribution

Package Type

-