Duns Number:022721133
Device Description: NebuTech® HDN® Nebulizer with inhalation valve, universal mask adaptor, mouthpiece, 7’ (2. NebuTech® HDN® Nebulizer with inhalation valve, universal mask adaptor, mouthpiece, 7’ (2.1 m) supply tube and female thread grip connector.
Catalog Number
8960TG-7
Brand Name
NebuTech®
Version/Model Number
8960TG-7
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,K961476
Product Code
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
5f9415ea-0ca1-408f-8bcd-4cbc35545439
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10607411890434
Quantity per Package
10
Contains DI Package
00607411890437
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 |