Catalog Number

200402

Brand Name

BioGenesis Fertility Lubricant

Version/Model Number

2oz

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

PEB

Product Code Name

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

Public Device Record Key

3fa4db1c-6256-49ab-b526-1a61d35b528e

Public Version Date

April 20, 2022

Public Version Number

1

DI Record Publish Date

April 12, 2022

Package DI Number

30893268000674

Quantity per Package

24

Contains DI Package

00893268000673

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case