Catalog Number

48556

Brand Name

STAT PROFILE

Version/Model Number

ULTRA/CCX

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

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

K110648,K110648

Product Code

CFA

Product Code Name

ELECTRODE, ION SPECIFIC, MAGNESIUM

Public Device Record Key

6fa3ba44-18fa-4c78-9cf3-4fc7f4da96e9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10385480485569

Quantity per Package

4

Contains DI Package

00385480485562

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton