Catalog Number

42014

Brand Name

STAT PROFILE

Version/Model Number

PHOX ULTRA

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

-

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

K110648,K110648

Product Code

BXX

Product Code Name

CALIBRATOR, PRESSURE, GAS

Public Device Record Key

6d42a07c-cd6d-43cd-9040-1bbd242b322d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10385480420140

Quantity per Package

1

Contains DI Package

00385480420143

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box