Catalog Number

-

Brand Name

McKesson

Version/Model Number

768-641-11AMMM

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

bff6e184-9a3b-43b4-9d27-c7883c9e249f

Public Version Date

September 21, 2018

Public Version Number

1

DI Record Publish Date

August 21, 2018

Package DI Number

40612479233810

Quantity per Package

12

Contains DI Package

10612479233802

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case