Catalog Number

-

Brand Name

DPM

Version/Model Number

313-5559

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

CAP

Product Code Name

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Public Device Record Key

d6f106f1-e064-4aa9-883d-77f13c902fae

Public Version Date

November 11, 2019

Public Version Number

2

DI Record Publish Date

October 30, 2018

Package DI Number

10841470110892

Quantity per Package

100

Contains DI Package

00841470110895

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-