Catalog Number

-

Brand Name

Manometer

Version/Model Number

10-55381

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"

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

K954486,K954486

Product Code

CAP

Product Code Name

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

Public Device Record Key

bf7b66b8-892a-423a-91aa-c25fc6d53f5a

Public Version Date

April 09, 2020

Public Version Number

4

DI Record Publish Date

May 06, 2016

Package DI Number

30641043553811

Quantity per Package

20

Contains DI Package

10641043553817

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-