Catalog Number

5438403

Brand Name

LEADER

Version/Model Number

5438403

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

K132086,K132086,K132086,K132086

Product Code

NBW

Product Code Name

SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Public Device Record Key

99058f2c-9a9c-47ed-aab3-e9fc9501cf98

Public Version Date

July 02, 2021

Public Version Number

2

DI Record Publish Date

October 22, 2018

Package DI Number

50096295134419

Quantity per Package

6

Contains DI Package

30096295134415

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE