Catalog Number

EDOAP-3104-25

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

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

ce4653b1-9314-40ac-a022-f15b06a71d97

Public Version Date

July 25, 2022

Public Version Number

4

DI Record Publish Date

June 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-