Catalog Number

-

Brand Name

BIOS

Version/Model Number

BD240

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

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

c011a5b0-0d57-4772-8cc4-f973aa43aea9

Public Version Date

March 14, 2022

Public Version Number

1

DI Record Publish Date

March 04, 2022

Package DI Number

20057475242408

Quantity per Package

2

Contains DI Package

00057475242404

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case