Duns Number:141668116
Device Description: Adult Nebulizer Kits - Disposable - w/ Jet Nebulizer, Aerosol Mask, 7ft O2 Tubing - 50/cas Adult Nebulizer Kits - Disposable - w/ Jet Nebulizer, Aerosol Mask, 7ft O2 Tubing - 50/case
Catalog Number
RES090
Brand Name
Sunset Healthcare Solutions Disposable Nebulizer Kit w/Aerosol Mask
Version/Model Number
RES090
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
e3502f4c-979e-4752-a326-bf35d7d51e80
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10848530060784
Quantity per Package
50
Contains DI Package
00848530060787
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 160 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 68 |