Catalog Number

/

Brand Name

cigii

Version/Model Number

B15

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200437,K200437

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

ecb22726-1b30-48be-b867-b2296e9dfc89

Public Version Date

March 01, 2022

Public Version Number

1

DI Record Publish Date

February 21, 2022

Package DI Number

16927709415168

Quantity per Package

20

Contains DI Package

06927709415161

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton