Catalog Number

-

Brand Name

McKesson

Version/Model Number

162-1130

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

KMI

Product Code Name

Monitor, Bed Patient

Public Device Record Key

9db91671-4b24-43a7-bf8a-af84780ee006

Public Version Date

May 18, 2020

Public Version Number

1

DI Record Publish Date

May 08, 2020

Package DI Number

40612479215083

Quantity per Package

72

Contains DI Package

10612479215075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case