Catalog Number

2013068-001

Brand Name

Vital Signs

Version/Model Number

2013068-001

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

b1f855c9-e1ed-43ee-860a-0bef36a30ec5

Public Version Date

August 05, 2022

Public Version Number

6

DI Record Publish Date

September 21, 2016

Package DI Number

20885403251907

Quantity per Package

10

Contains DI Package

10885403251900

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box