Catalog Number

776-641BKKIT1

Brand Name

Pro's Combo V™

Version/Model Number

776-641BKKIT1

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

6c56e417-6836-4ea9-b5d7-dea0d2c345af

Public Version Date

November 02, 2020

Public Version Number

1

DI Record Publish Date

October 24, 2020

Package DI Number

00634782599577

Quantity per Package

12

Contains DI Package

00634782098193

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case