Duns Number:627572217
Device Description: NEBULIZER SET 6CC (ML) W/ADULT MASK AND STANDARD CONNECTOR
Catalog Number
9003105
Brand Name
CUSTOMED
Version/Model Number
712057143105
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K091272,K091272
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
0a90df31-45e1-4652-b553-2b151ee2fe45
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
M20890031052
Quantity per Package
50
Contains DI Package
M20890031050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
50/CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |