Catalog Number

-

Brand Name

B WELL

Version/Model Number

ePA-09B4

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K134029,K134029,K134029

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

cab40420-9a2c-404f-af7c-9e0682818142

Public Version Date

August 19, 2021

Public Version Number

1

DI Record Publish Date

August 11, 2021

Package DI Number

16947468500202

Quantity per Package

1

Contains DI Package

06947468556455

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX