Catalog Number

-

Brand Name

JOKYLE

Version/Model Number

B15

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

K172171,K172171

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

18426a3e-c6b2-483a-bbbc-1cf9ef54a0c8

Public Version Date

July 06, 2020

Public Version Number

1

DI Record Publish Date

June 28, 2020

Package DI Number

16927709415045

Quantity per Package

20

Contains DI Package

06927709415048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-