Duns Number:023904428
Device Description: Compressor Nebulizer System
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-3665LT
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
-
Product Code
BTI
Product Code Name
Compressor, Air, Portable
Public Device Record Key
231df587-1fdf-486b-9ce5-385deae65cd2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 03, 2017
Package DI Number
20612479216918
Quantity per Package
1
Contains DI Package
10612479216904
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |