Catalog Number

-

Brand Name

Preview

Version/Model Number

PRE-HCG-25SE

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)

Yes

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

b36c30d7-e9b7-48d6-90d1-43099fd30113

Public Version Date

February 28, 2020

Public Version Number

1

DI Record Publish Date

February 20, 2020

Package DI Number

10816862021728

Quantity per Package

120

Contains DI Package

00816862021721

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-