Catalog Number

-

Brand Name

bioland

Version/Model Number

2005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K201467,K201467

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

17e4cff7-e312-4c00-acfe-f4867e55ca05

Public Version Date

November 24, 2020

Public Version Number

1

DI Record Publish Date

November 16, 2020

Package DI Number

16939184610020

Quantity per Package

20

Contains DI Package

06939184610023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-