Duns Number:022721133
Device Description: NebuTech® HDN® Nebulizer with inhalation and exhalation valve, universal mask adaptor, mo NebuTech® HDN® Nebulizer with inhalation and exhalation valve, universal mask adaptor, mouthpiece, 14’ (4.2 m) supply tube
Catalog Number
8960-14
Brand Name
N/A
Version/Model Number
8960-14
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
-
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
K961476,K961476
Product Code
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
756497a7-bc87-43e7-822a-467e0a459ae2
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10607411918084
Quantity per Package
50
Contains DI Package
00607411918087
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 | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |