Duns Number:079628327
Device Description: Asthma Rescue Kit, Pediatric Mask, HEPA Filter
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
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
7b5849d2-6301-4556-8752-beeeecddd806
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 09, 2017
Package DI Number
00857863007833
Quantity per Package
5
Contains DI Package
00857863007765
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
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 |