Catalog Number

ACDOA-1144-25

Brand Name

Areta Multi-Drug Test Cup (25 tests kit)

Version/Model Number

ACDOA-1144

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

984d3181-39a2-4b94-b29c-836ac32b92f9

Public Version Date

July 25, 2022

Public Version Number

4

DI Record Publish Date

June 29, 2020

Package DI Number

10810038630646

Quantity per Package

4

Contains DI Package

00810038630649

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton