Catalog Number

-

Brand Name

PARAMED

Version/Model Number

CM-BPM

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

K090014

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

296b8c9e-f272-4cfa-b1a7-c90448019a32

Public Version Date

May 21, 2019

Public Version Number

1

DI Record Publish Date

May 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-