Catalog Number

-

Brand Name

McKesson

Version/Model Number

5055

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"

-

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

K092052,K092052,K092052

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

2ebbbe6a-23c9-4694-82c0-6d47b3105999

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

40612479197143

Quantity per Package

20

Contains DI Package

20612479197132

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case