Duns Number:830437997
Device Description: Dexter Dragon Compressor Nebulizer
Catalog Number
11-510
Brand Name
Veridian
Version/Model Number
11-510
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
-
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
b9187099-5d3c-4b71-850b-157843f5ef2e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
10845717002841
Quantity per Package
4
Contains DI Package
00845717002844
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 127 |