Catalog Number

/

Brand Name

Wellue

Version/Model Number

B02S

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

2f7eb411-10d0-4ce1-9a7b-4185abcb166c

Public Version Date

January 07, 2022

Public Version Number

1

DI Record Publish Date

December 30, 2021

Package DI Number

16927709402441

Quantity per Package

20

Contains DI Package

06927709402444

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton