Catalog Number

-

Brand Name

Be Sure

Version/Model Number

Midstream

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NGA

Product Code Name

Test, Follicle Stimulating Hormone (Fsh), Over The Counter

Public Device Record Key

49647380-64b3-45f4-96cb-4c711ff0608c

Public Version Date

July 27, 2020

Public Version Number

1

DI Record Publish Date

July 17, 2020

Package DI Number

10748349000707

Quantity per Package

48

Contains DI Package

00748349000700

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case