Catalog Number

900604-004

Brand Name

Vital Signs™

Version/Model Number

900604-004

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

-

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

43d46043-47ee-4d91-b81f-2713470f835d

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

January 28, 2021

Package DI Number

20190752140896

Quantity per Package

50

Contains DI Package

10190752140899

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-