Catalog Number

-

Brand Name

Sunbean

Version/Model Number

HL858A2-LT

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

K190507,K190507

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

79f0a2df-4e8c-4987-a986-9e6141bf362c

Public Version Date

October 19, 2021

Public Version Number

1

DI Record Publish Date

October 11, 2021

Package DI Number

14719872483295

Quantity per Package

4

Contains DI Package

04719872483298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-