Catalog Number

900604-003

Brand Name

Vital Signs

Version/Model Number

900604-003

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

f2a49fea-45d8-4dd2-8cfa-769af5edd422

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

20885403251037

Quantity per Package

50

Contains DI Package

10885403251030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box