Catalog Number

-

Brand Name

iProvèn

Version/Model Number

FK-127-HCGtest

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

JHI

Product Code Name

Visual, Pregnancy Hcg, Prescription Use

Public Device Record Key

fa2e1545-25c4-4087-9e8d-d6154f3b1f16

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-