Catalog Number

78010

Brand Name

Vital Signs™

Version/Model Number

78010

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

CCL

Product Code Name

ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Public Device Record Key

1dd52475-a521-41df-8e39-fe95713335e7

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

April 02, 2021

Package DI Number

20190752111346

Quantity per Package

10

Contains DI Package

10190752111349

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box