Duns Number:092673953
Device Description: Mini-Heart Hi-Flo Continuous Nebulizer, Super Spike Mask, 7'
Catalog Number
-
Brand Name
Mini-Heart
Version/Model Number
100625
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
K920443,K920443
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
fe3a902d-eaab-4e9c-b683-0d972e76daaa
Public Version Date
November 08, 2019
Public Version Number
1
DI Record Publish Date
October 31, 2019
Package DI Number
10709078008198
Quantity per Package
25
Contains DI Package
00709078008191
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |