Healthline, ARK - Asthma Rescue Kit - Asthma Rescue Kit, Pediatric Mask, HEPA Filter - Medi/Nuclear Corporation, Inc.

Duns Number:079628327

Device Description: Asthma Rescue Kit, Pediatric Mask, HEPA Filter

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More Product Details

Catalog Number

-

Brand Name

Healthline, ARK - Asthma Rescue Kit

Version/Model Number

ARK-27

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

7b5849d2-6301-4556-8752-beeeecddd806

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 09, 2017

Additional Identifiers

Package DI Number

00857863007833

Quantity per Package

5

Contains DI Package

00857863007765

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"MEDI/NUCLEAR CORPORATION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 90