Duns Number:141668116
Device Description: Pediatric Nebulizer Kit - Disposable - w/ Jet Nebulizer, Pediatric Aerosol Mask, 7ft O2 tu Pediatric Nebulizer Kit - Disposable - w/ Jet Nebulizer, Pediatric Aerosol Mask, 7ft O2 tube - 50/cs
Catalog Number
RES092
Brand Name
Sunset Healthcare Solutions Pediatric Disposable Nebulizer Kit w/ Aerosol Mask
Version/Model Number
RES092
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
4878e4b0-59ac-473a-849c-448f66038482
Public Version Date
June 13, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |