Catalog Number

740-MCC1

Brand Name

System 5™

Version/Model Number

740-MCC1

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

2fd641ad-7a45-46d2-a015-08717eb3573c

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 29, 2020

Package DI Number

00634782597825

Quantity per Package

4

Contains DI Package

00634782096441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case