Catalog Number

-

Brand Name

Koogeek

Version/Model Number

BP2

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

K134029,K134029,K134029

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

e5427208-f1b4-48d5-aa57-cd1b25b04c54

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

November 03, 2017

Package DI Number

16947468535679

Quantity per Package

1

Contains DI Package

06947468535672

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

1pcs/box