Catalog Number

/

Brand Name

C0MFIER

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"

-

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

100f0497-4f07-4347-a7b5-8a204dd2f745

Public Version Date

September 30, 2021

Public Version Number

1

DI Record Publish Date

September 22, 2021

Package DI Number

16927709415137

Quantity per Package

20

Contains DI Package

06927709415130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton