Catalog Number

DWDOA-754-5BX-A

Brand Name

Prime Screen

Version/Model Number

DWDOA-754-5BX-A

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

K202567,K202567,K202567

Product Code

NFT

Product Code Name

Test, Amphetamine, Over The Counter

Public Device Record Key

15efdb2a-0ce4-4d25-a358-04f16a765183

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

February 11, 2022

Package DI Number

10816862023678

Quantity per Package

90

Contains DI Package

00816862023671

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-