STAT PROFILE - Stat Profile pHOx/Basic/BiopHOx W/R Pump Tubing - NOVA BIOMEDICAL CORPORATION

Duns Number:070617139

Device Description: Stat Profile pHOx/Basic/BiopHOx W/R Pump Tubing Kit

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

49847

Brand Name

STAT PROFILE

Version/Model Number

PHOX/BASIC/BIOPHOX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K014295

Product Code Details

Product Code

CHL

Product Code Name

ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Device Record Status

Public Device Record Key

0e81d97c-da77-46a5-a6ef-95c6cf44cb07

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVA BIOMEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 165
2 A medical device with a moderate to high risk that requires special controls. 210