Catalog Number

-

Brand Name

Manometer

Version/Model Number

10-55366

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

4b988d1c-1a36-4b71-8f81-c14956fd6e34

Public Version Date

April 09, 2020

Public Version Number

4

DI Record Publish Date

March 03, 2016

Package DI Number

30641043553668

Quantity per Package

20

Contains DI Package

10641043553664

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-