Catalog Number

704-0004

Brand Name

SPACELABS HEALTHCARE

Version/Model Number

91517

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

K031124,K031124

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

863fb4ff-257e-46cb-ac1c-1b317eda67b3

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

December 11, 2019

Package DI Number

30841522126257

Quantity per Package

24

Contains DI Package

10841522126253

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX