Duns Number:141668116
Device Description: Adult Neb Kit - Disposable - w/ Jet Nebulizer, T-Piece, Mouthpiece, 6-inch Tube, 7ft O2 tu Adult Neb Kit - Disposable - w/ Jet Nebulizer, T-Piece, Mouthpiece, 6-inch Tube, 7ft O2 tube - 50/cs
Catalog Number
RES091
Brand Name
Sunset Healthcare Solutions Disposable Nebulizer Kit w/T Mouthpiece
Version/Model Number
RES091
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
7e31a41a-7153-4f2f-99df-3f600fe5e0e8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
10848530060791
Quantity per Package
50
Contains DI Package
00848530060794
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 |