Catalog Number

-

Brand Name

GRX Medical

Version/Model Number

BP-02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 28, 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"

Yes

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

K082542,K082542

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

cf0006c4-eca2-4033-a304-1df27d881057

Public Version Date

December 03, 2019

Public Version Number

1

DI Record Publish Date

November 25, 2019

Package DI Number

26970366970096

Quantity per Package

50

Contains DI Package

06970366970092

Package Discontinue Date

November 28, 2019

Package Status

Not in Commercial Distribution

Package Type

MASTER CARTON