Catalog Number

-

Brand Name

Easy@Home Multi-Drug Screen Test (25 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

K133968,K133968,K133968

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

74923fff-0bdd-45aa-9fd4-f1c1454876f1

Public Version Date

July 25, 2022

Public Version Number

9

DI Record Publish Date

September 15, 2016

Package DI Number

10850253007434

Quantity per Package

20

Contains DI Package

00850253007437

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-