Catalog Number

-

Brand Name

bab and brad

Version/Model Number

C02

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)

-

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

201a2a49-bf9f-46fd-807b-1c3ae32eff73

Public Version Date

March 10, 2021

Public Version Number

1

DI Record Publish Date

March 02, 2021

Package DI Number

16927709486038

Quantity per Package

20

Contains DI Package

06927709486031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-