Catalog Number

-

Brand Name

iHealth

Version/Model Number

EGS-2003

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

e6d5158c-0cd0-4a94-9e7f-a17e275534f5

Public Version Date

February 11, 2019

Public Version Number

1

DI Record Publish Date

January 09, 2019

Package DI Number

20856362005191

Quantity per Package

50

Contains DI Package

10856362005194

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-