Duns Number:004135503
Device Description: Anti-Static Holding Chamber for use with MDIs. Adult Sized Mask included.
Catalog Number
-
Brand Name
Clever Choice
Version/Model Number
Large Anti-Static Holding Chamber
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
NVP
Product Code Name
Holding Chambers, Direct Patient Interface
Public Device Record Key
2cc0f0d1-fb63-4a92-9d54-24684940b54a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 07, 2017
Package DI Number
10898302001385
Quantity per Package
12
Contains DI Package
00898302001388
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |