Catalog Number

-

Brand Name

PANACARE

Version/Model Number

B63

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

d7b1b6c2-891a-4736-a7cf-443f75604740

Public Version Date

March 02, 2021

Public Version Number

1

DI Record Publish Date

February 22, 2021

Package DI Number

16927709463176

Quantity per Package

45

Contains DI Package

06927709463179

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-