Catalog Number

21-FHCN-16706

Brand Name

CNAP® controller

Version/Model Number

V4.1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 18, 2019

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

K082599

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

a182d57f-1b99-4bc9-95ae-864fc5cd6f78

Public Version Date

November 20, 2019

Public Version Number

2

DI Record Publish Date

October 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-