Catalog Number

EDOAP-1124-1

Brand Name

Easy@Home Multi-Drug Screen Test (1 test kit)

Version/Model Number

EDOAP-1124

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

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K202567

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

253d3013-c634-481c-b3e7-144f28104dc3

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-