Catalog Number

-

Brand Name

AimStrip Tandem blood glucose test strips

Version/Model Number

ILM-0001A

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130295

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

5db1f632-16e6-450c-8dc5-baccdc068d48

Public Version Date

March 23, 2020

Public Version Number

1

DI Record Publish Date

March 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-