Catalog Number

-

Brand Name

CVS

Version/Model Number

557102

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

-

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

LFD

Product Code Name

Saliva, Artificial

Public Device Record Key

14260e15-3f33-46b6-bda9-dc71f4e8d2dd

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Package DI Number

30050428396842

Quantity per Package

12

Contains DI Package

00050428396841

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case