Catalog Number

400149-002

Brand Name

Vital Signs™

Version/Model Number

400149-002

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

-

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

dcc5b2aa-deda-47f4-baa0-6a085cb0a2cf

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

March 05, 2021

Package DI Number

50190752140828

Quantity per Package

150

Contains DI Package

10190752140820

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case