Catalog Number

-

Brand Name

bioland

Version/Model Number

A221-2

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

K202934,K202934

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

825d55b3-1b9a-4c70-9478-f672774fc908

Public Version Date

March 15, 2021

Public Version Number

1

DI Record Publish Date

March 06, 2021

Package DI Number

16939184610099

Quantity per Package

20

Contains DI Package

06939184610092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-