Catalog Number

-

Brand Name

Healthline Medical Inc. - Asthma Rescue Kit

Version/Model Number

ARK-3

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080657,K080657

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

94bf4db2-273b-4214-93d1-bb6d5fdbb913

Public Version Date

November 17, 2020

Public Version Number

1

DI Record Publish Date

November 09, 2020

Package DI Number

00850022357442

Quantity per Package

5

Contains DI Package

00850022357008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-