Catalog Number

-

Brand Name

McKesson

Version/Model Number

1158

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K024197,K024197

Product Code

HEP

Product Code Name

Monitor, Blood-Flow, Ultrasonic

Public Device Record Key

453afe22-f3a1-4f04-8181-478992ab2579

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-