Catalog Number

-

Brand Name

Rite Aid

Version/Model Number

DNE1383C1

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

5fec0680-d50b-42c6-87bd-32d3e0ce5c9f

Public Version Date

August 23, 2022

Public Version Number

1

DI Record Publish Date

August 15, 2022

Package DI Number

20118225157882

Quantity per Package

6

Contains DI Package

10118225157885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner