Catalog Number

775GPK-N

Brand Name

Prosphyg™

Version/Model Number

775GPK-N

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

423969ba-1291-4df1-add0-77d2a7a24c7c

Public Version Date

November 02, 2020

Public Version Number

1

DI Record Publish Date

October 24, 2020

Package DI Number

00634782599812

Quantity per Package

12

Contains DI Package

00634782098421

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case