Catalog Number

-

Brand Name

NIFometer

Version/Model Number

10-34000

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

K032593,K032593

Product Code

BXR

Product Code Name

Meter, Airway Pressure (Inspiratory Force)

Public Device Record Key

930b7f48-0e8d-424b-8bd4-fa44a72c1e1e

Public Version Date

July 03, 2020

Public Version Number

5

DI Record Publish Date

April 01, 2016

Package DI Number

30641043340008

Quantity per Package

20

Contains DI Package

10641043340004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-