Catalog Number

-

Brand Name

Easy@Home Multi-Drug Screen Test (5 tests/kit)

Version/Model Number

EDOAP-3104

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,K202567,K202567

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

0b844615-0b63-4422-828c-350d0fc5cc7f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

February 17, 2022

Package DI Number

10810038630622

Quantity per Package

36

Contains DI Package

00810038630625

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton