Duns Number:656854379
Catalog Number
RF1 Nebulizer w/Neb-1.T Valve Kit, 22M, 22M
Brand Name
Neb.Plus
Version/Model Number
NV33
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZA
Product Code Name
Connector, Airway (Extension)
Public Device Record Key
8469b305-d2f4-4d7b-be51-c25fa2c68c19
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 15, 2015
Package DI Number
44710810100558
Quantity per Package
25
Contains DI Package
04710810100550
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 29 |
2 | A medical device with a moderate to high risk that requires special controls. | 22 |