Duns Number:141668116
Device Description: Reusable Nebulizer Kit, includes: T-Piece, Mouthpiece, 7ft Supply Tube, Corrugated Reserv Reusable Nebulizer Kit, includes: T-Piece, Mouthpiece, 7ft Supply Tube, Corrugated Reservoir Tube and Nebulizer Bottle.
Catalog Number
RES093
Brand Name
Sunset Healthcare Solutions Reusable Nebulizer Kit
Version/Model Number
RES093
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"
-
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
-
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
4e94e90e-4f08-46df-ab9f-93faf4627921
Public Version Date
September 21, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10848530062337
Quantity per Package
10
Contains DI Package
00848530062330
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 | 160 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 68 |