Catalog Number

-

Brand Name

McKesson

Version/Model Number

01-641BKGM

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

LDE

Product Code Name

Stethoscope, Manual

Public Device Record Key

cd6e088a-e465-4f2f-9945-eeaa61e960f9

Public Version Date

March 24, 2020

Public Version Number

1

DI Record Publish Date

March 16, 2020

Package DI Number

00612479116764

Quantity per Package

20

Contains DI Package

00612479105119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case