Catalog Number

50428654200

Brand Name

CVS Health At Home

Version/Model Number

STI collection 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

LIO

Product Code Name

Device, Specimen Collection

Public Device Record Key

fb2588e9-62f3-4ec1-b6b1-9bff04bf4bc0

Public Version Date

August 01, 2022

Public Version Number

1

DI Record Publish Date

July 23, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-