Catalog Number

-

Brand Name

GLOBAL HEALTHCARE

Version/Model Number

63-4532

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

K143150,K143150

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

b0914b80-f356-46ea-bccd-4d1837de05aa

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

February 10, 2017

Package DI Number

40872237001109

Quantity per Package

25

Contains DI Package

00872237001101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE