Catalog Number

-

Brand Name

Arvolife

Version/Model Number

Fertility Kit

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

Yes

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

-

FDA Premarket Submission

-

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

5252634e-6561-4bda-90b8-b96d0856e887

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 27, 2018

Package DI Number

10851950008045

Quantity per Package

60

Contains DI Package

00851950008048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-