Catalog Number

704-0022

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

9ee5d0ed-bd5e-4fa2-9f0d-b2f4e0a841d3

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

December 11, 2019

Package DI Number

30841522126363

Quantity per Package

10

Contains DI Package

10841522126369

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX